글로벌 규제 모니터
2026년 9월 2주차 규제뉴스

Hazardous drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination.

Specifically, 1) Your firm routinely produces hazardous drug products on shared tablet press equipment without employing a deactivating agent as part of the cleaning process between batches, relying solely on <Redacted B4>. From 6/3/2026 through 6/9/2026, your firm produced the following <Redacted B4> hazardous drug products sequentially on tablet press NP4-2405 with only <Redacted B4> cleaning performed between each product: a. Tadalafil 8.5mg + Enclomiphene citrate 12.5mg tablets lots DFJRJFLEQPRS and QHKTRRHEKQFE b. Tadalafil 8.5mg + Finasteride 1.2mg + Minoxidil 3mg + Biotin 2.5mg + Vit B12 !mg + Vit 03 0.05mg + L-Theanine 50mg Tablets lots IKTIDKQPCGUT and TIGISITHFHGD C. Naltrexone HCL 14mg + Topiramate 44mg Vitamin Bl2 1mg Tablets lots UFISFTCFFTPS and DLCQHEGLUTQE 2) Your firm routinely performs hazardous drug powder weighing and sifting operations in Room I04, your designated hazardous weighing room, under conditions that do not consistently meet the required negative air pressure specifications. Review of the Building Management System (BMS) data for Room 104 from 5/13/2026 through 6/10/2026 revealed approximately 56 pressure differential alarm events, with excursion dura

Materials were exposed to lower than ISO 5 quality air.

Specifically, On 5/16/2026, during production of Semaglutide 5mg/2mL Solution for Injection, lot CERKTLEQQQIJ, we observed, via video review, the following poor transfers of material into the !SO­S hood resulting in the material being exposed to the IS0-7 environment.

Use of ingredients not intended for pharmaceutical use in non-sterile drug production.

Specifically, Your firm makes Minoxidil 1.5mg + Biotin 2.5mg chewable gummy products using <Redacted B4> water that has not been tested. This water is used in your firm's formulation of the gummy product. Untested <Redacted B4> water was used in the production of Minoxidil 1.5mg + Biotin 2.5mg chewable gummy lot UGDFEUSJHFGJ. *DATES OF INSPECTION 6/08/2026 (Mon), 6/09/2026 (Tue), 6/10/2026 (Wed), 6/11/2026 (Thu), 6/12/2026 (Fri), 6/15/2026 (Mon), 6/16/2026 (Tue), 6/17/2026 (Wed)

Your firm released drug product in which the strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.

Specifically, a technician identified a suspected glass particle in one vial during visual inspection of Liraglutide Injection, 6 mg/mL, lot 042026CH01. BUD 07/19/26. The OOS investigation authorized a technician to recover <Redacted B4> and then fill the solution as Liraglutide Injection. 6 mo/mL, lot 051426CR26, BUD 08/12/26. There is inadequate stability data to support the approximately 90-day BUD assigned to the <Redacted B4> lot that was originally formulated and <Redacted B4> on 04/20/26. The new BUD is 24 days beyond the original 90-day BUD for the solution. There was no confirmation of the particle identity or its source. Your firm dispensed, <Redacted B4> units from the <Redacted B4> lot. Examples include Rx <Redacted B4> delivered 07/15/26; RxfH <Redacted B4>, delivered 07/10/26; Rx <Redacted B4>, delivered 07/08 26; and Rx <Redacted B4> delivered 06 0372026.

Failure to conduct media fills that closely simulate aseptic production operations under the worst-case, most-challenging, and stressfol conditions.

Specifically, media fill procedures and executed records do not reflect the various production activities I watched. Your firm currently aseptically fills about <Redacted B4> vials per day, and filled about <Redacted B4> lots of sterile injectable drugs in the previous two years. A. Media fills do not simulate the most challenging production conditions. I watched <Redacted B4> technicians simultaneously fill. stopper, and cap vials from two lots inside the same ISO 5 hood during filling of multiple lots from Semaglutide Injection, 2.5 mg/mL stock solution lots 072126CRS1, 072126CRS2, and 072226CH-S25-01; and Tirzepatide-Methylcobalamin Injection, 17 mg-l00mcg/mL stock solution lots 072126CR-TM17-01 and 072726CH-TM17-01. Technicians fill, stopper. and cap vials independently during media fill. B. Technicians used dehydrated <Redacted B4> modified, <Redacted B4> during the most recent media fills for <Redacted B4> technicians in July 2026. The manufacturer's information indicates this <Redacted B4> is intended for the selective enrichment of enterohemorrhagic E.coli in foods in a laboratory setting. Growth promotion on the manufacturer's certificate of analysis docmnent growth of sev

Smoke studies were inadequately perfomed under dynamic conditions.

Specifically, A. One technician, one syringe, and one vial present in the ISO 5 hoods during the smoke studies conducted in January 2026 was not representative of routine production. Items I observed under the hood during filling of multiple lots from Semaglutide Injection, 2.5 mg/mL stock solution lots 072126CRS1, 072126CRS2, and 072226CH-S25-01; and Tuzepatide:Methylcobalamul Injection, 17 mg-1OOmcg/mL stock solution lots 072126CR-TM17-01 and 072726CH-TM17-01 mclude: 4'{b) (1 technicians. one repeater pump, <Redacted B4> bags and tubing and hanging from the IV bar, one tray of glass vials, one bag of stoppers, one bag or caps, multiple forceps, a sleeve of <Redacted B4> plates, and other items. B. Operations within the ISO 3 hood and ISO 7 buffer room were not representative of routine production conditions. One technician sunulated ptmcniring a vial septic while one person held the handheld smoke generator during the smoke study. Conditions I observed that were not evaluated durmg the smoke study include <Redacted B4> technicians filling. stoppering, and capping vials simultaneously in the same ISO 5 hood. C. Insufficient smoke was introduced into the primary workspace to adequa

Materials were exposed to lower than ISO 5 quality air.

Specifically, I observed several sterile items exposed in the ISO 7 buffer room during filling of multiple lots from Semaglutide Injection, 2.5 mg/mL stock solution lots 072126CRS1, 072126CRS2. ai1d 072226CH-S25-01; atid Tuzepatide-Methylcobalamul Injection, 17 mg­ l00mc2/mL stock solution lots 072126CR-TM17-01 and 072726CH-TM17-01. A:· Technicians remove sterile wipes from the package and place them on top of the package on a table in the ISO 7 Hood Room (buffer room). I saw wipes remain exposed to the environment for more than one hour and observed multiple bags of caps placed directly on top ofthe wipes. Technicians sprayed sterile <Redacted B4> on these wipes and used them to disinfect surfaces inside the ISO 5 hoods. B. F orceps purchased sterile were stored exposed in the ISO 7 buffer room for an indefinite amount of time, sanitized with <Redacted B4>, and then used to put stoppers into filled vials of semaglutide injection. C. <Redacted B4> trays used as a direct contact surface for vials and stoppers inside the ISO 5 hood are sterilized in the house and then remain exposed in the ISO 7 buffer room for an unspecified amount of time.

Personnel were observed conducting aseptic manipulations where the movement of"first air" in tHE ISO 5 area is blocked or disrupted.

Specifically, I observed aseptic technique deficiencies during filling of multiple lots from Semaglutide Injection, 2.5 mg/mL stock solution lots 072126CRS 1, 072126CRS2, and 072226CH-S25-01; and Tirzepatide-MethylcobalamL Injection, 17 mg-lO0mcg/mL stock solution lots 072126CR-TM17-01 and 072726CH-TM17-01. A. Multiple technicians filled Semaglutide Injection and Tirzepatide Injection using tubing connected to the repeater pump without a filling needle. The lack of filling needle required the technician to place their gloved hand directly over every vial during filling. The technicians' gloved hands moved over the opening of every vial as they filled the row from <Redacted B4> to <Redacted B4> B. Technicians poured a portion of the rubber stoppers from the manufacturer's bag onto <Redacted B4> trays outside both ISO 5 <Redacted B4> airflow hoods: i. <Redacted B4> technicians simultaneously and continuously reached over a pile of about <Redacted B4> stoppers on a nonsterile tray. They used approxunately 5-inch-long forceps to pick up stoppers and seat them into filled vials of Semaglutide Injection. ii. Technicians placed the bag with the remaining stoppers between the HEPA filters

Personnel were observed touching equipment or other surfaces located outside of the ISO S area with gloved hands and then proceeding with aseptic processing without changing or sanitizing gloves.

Specifically, a technician repeatedly placed their gloved hand on the edge of the work surface in the ISO 5 hood for up to two minutes at a time during filling of Semaglutide Injection, 2.5 mg/mL. lot 072726KH-S25-0l. Approximately half or more of the gloved hand was outside of the ISO S hood and then reentered without sanitizing with sterile <Redacted B4>

Inadequate post-use filter-integrity testing on filters used to sterilize drug products.

Specifically, the <Redacted B4> digital pressure gauge, S/N <Redacted B4> attached to the <Redacted B4> tester has been in-use about three years but has not been calibrated to confirm the accuracy of readings for this critical test. Personnel record pressure readings from this gauge during <Redacted B4> tests for all sterile drug lots. Examples of drug lots produced and dispensed after <Redacted B4> testing witli this gauge include: • Semaglutide Injection. 2.5 mg/mL. lot 061526CH06 • Semaglutide-Glycine Injection, 5 mg-2mg/mL, lot 060826CH02 • Tirzepatide-Methylcobalanun (MB12) Injection, 8.5 mg-100 mcg/mL, lot 060526KH12 • Li.raglutide Injection, 6 mg/mL, lot 051426CR26

Personnel inadequately sanitized gloves to prevent contamination.

Specifically, technicians repeatedly failed to thoroughly sanitize gloved hands during filling of multiple lots from Semaglutide Injection, 2.5 mg/mL stock solution lots 072126CRS1 , 072126CRS2, and 072726KH-S25-01; and Tirzepatide-Methylcobalamin Injection, 17 mg-l00mcg/mL stock solution lot 072126CR-TM17-01.

Hazardous drugs were produced without providing adequate containment.

segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination. Specifically, A. The technician did not change wipes with sufficient frequency during the deactivation and decontamination process of capsule equipment, utensils and the BSC after producing Clomiphene Capsules, lot 07282026RW01. The technician used one approximately <Redacted B4> inch wipe to decontaminate the entire interior of the BSC and used one wipe to decontaminate all the parts of the capsule equipment. B. The technician did not deactivate and decontaminate the pen used to record capsule weights in the batch record during production of Clomiphene Capsules, lot 07282026RW0 1. *DATES OF INSPECTION 7/21/2025 (Tue), 7/22/2026 (Wed), 7/23/2026 (Thu), 7/24/2026 (Fri), 7/27/2026 (Mon), 7/28/2026 (Tue), 7/29/2026 (Wed), 7/30/2026 (Thu), 7/31/2026 (Fri)

Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).

Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).

Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).

There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

Specifically, Your firm failed to adequately investigate Out-of-Specification (OOS) results for potency testing of sterile drug products manufactured during May 2024-June 2026. A review of deviation records revealed thirteen (13) OOS potency failures across multiple drug products and lots, indicates a recurring and systemic failure to maintain adequate process controls. All 00S were reportedly attributed to the contract testing laboratory and resolved via retesting at the same lab. Table below shows all the potency OOS: Deviation # Date Initiated Type Drug Product Lot Number(s) Close Date Vials DV24·051 September 19,2024 OOS Potency Triamcinolone Acetonide 091124·1 October 4, 2024 Redacted B 4 DV25-053 April 3, 2025 OOS Potency Morphine Sulfate 032625-1 April 9, 2025 DV25-054 April 7, 2025 OOS Methylprednisolon 033125-1 April 14, 2025

The responsibilities and procedures applicable to the quality control unit are not fully followed.

Specifically, Your quality control unit failed to exercise adequate oversight of the contract testing laboratory performing potency testing (refer to the table in Observation 1) as evidenced by: (1) Pattern of OOS invalidation without adequate QCU scrutiny Thirteen (13) Out-of-Specification (OOS) potency results were recorded over 26 months between May 2024 and June 2026 across four drug products (Triamcinolone Acetonide, Betamethasone Sodium Phosphate, Methylprednisolone Acetate, and Morphine Sulfate). Twelve (1 2) of these OOS results were invalidated and product was released without documented evidence that the quality control unit independently reviewed the contract laboratory's raw data, chromatograms, instrument logs and invalidation rationale. One result (Triamcinolone Acetonide 3mL, Lot 051526-1) was confirmed 00S, The QCU accepted the contract lab's invalidation conclusions in 12 of 13 cases without apparent independent verification. For DV25-058 (Betamethasone lot 091 225-1), the contract testing laboratory stated the root cause was undetermined. Your firm released the batch without any assignable cause of OOS and without initiating any CAPA.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.

Specifically, The environmental monitoring program ofyour firm allows for a CFU limit <Redacted B4> for gloved fingertips in an ISO 5 area. For a COMP compliant 503B facility, the action level must be any detected organism. Furthermore, your firm failed to investigate and identity the microbial growth recovered from the ISO 5 environment at the facility. All the compounded drug products were released for distribution. The environmental monitoring (EM) excursion records below document nine (9) microbial excursions occurring in ISO-5 classified areas between May 8, 2025, and June 24, 2026. Of these, five (5) involved gloved fingertip samples, three (3) involved personne] <Redacted B4> samples, and one (1) involved a surface sample. All samples yielded 1 CFU on <Redacted B4>, exceeding the action level of <Redacted B4> 1CFU established for ISO-5 areas. Only one excursion (No. 39, dated 2026-05-21) which involved a surface sample from location ISO <Redacted B4> was identified as a Bacillus Species. No other microbial excursions from ISO 5 environment were isolated and identified.

There is a failure of the quality control unit to secure their responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling.

and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. Specifically, A) You do not have procedures for documented review of retain samples. On 07/21/2026 and 07/22/2026 the inspection team reviewed retain samples of Semaglutide Injection and Semaglutide with Glycine Injection drug product vials and observed approximately 59 vials across <Redacted B4> contained white particles of varying size and quantity, of which you were previously unaware. PLOYEE(S) NAME ANO TITLE (Prwit or Type)

(Repeat) Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes.

(Repeat) There is a failure to thoroughly review any unexplained discrepancy, the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

(Repeat) Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas.

Specifically, A) The design of your <Redacted B4> sterile IV bag filling process lacks adequate aseptic and in-process material controls. This process was observed on 07/17/2026 during the compounding of Vancomycin 1.5g added to 250ml of 0. 9% Sodium Chloride (Injection For intravenous Use Only) Lot AC-017291. i) Unfinished in-process Sodium Chloride IV bags were observed to be unnecessarily moved into and through the ISO 5 aseptic filling environment without aseptic manipulation, only to be removed back into the adjacent ISO 7 environment for intermittent in-process weight checks before being re­introduced into the ISO 5 hood. ii) A support compounding operator was observed repeatedly handling both unfinished Sodium Chloride IV bags and finished Vancomycin in Sodium Chloride IV bags during in process weight checks, without adequate control over identification of finished and unfinished IV bags. E-Tv MPLO~EE(S ) SIG ATURE ~

Each component is not tested for confonnity with all appropriate written specifications for purity, strength, and quality.

Specifically, A) You do not test all received containers of at-risk API raw material <Redacted B4> or potential contamination within <Redacted B4> and <Redacted B4>. You release raw material <Redacted B4> for compounding sterile human injectable drugs based upon review of the supplier CoA. You use <Redacted B4> a raw material in Semaglutide Injection products, including but not limited lot AC-017165. B) Your firm releases critical raw materials for use in compounding before a specific identity test. Performance and review of identity testing occur after quality release. You neither require batches to be made exclusively with materials after a completed identity test nor have a process to ensure that compounded lots are withheld from distribution until all component raw materials have a completed identity test. For example, you released semaglutide <Redacted B4> for use in compounding on 01/12/2026. You began the compounding of lot AC-017165, Semaglutide 2.5mg/mL Stock Solution, on 02/17/2026, however you did not receive material identity test results from your contract lab on 02/23/2026.

(Repeat) Buildings used in the manufacture, processing, packing, or holding of a drug do not have the suitable construction and location to facilitate cleaning, maintenance, and proper operations.

Specifically, A) On 07/13/2026 the inspection team observed you storing bagged sterile gowning and opened boxes of bagged components and materials used for aseptic compounding including sterile vials, vial stoppers, syringes, sterile <Redacted B4> bag, and IV bags of Sodium Chloride Injection USP in a warehouse constructed with exposed wood and <Redacted B4>, -coated wall insulation. On 07/17/2026, the inspection team observed a non-integral package of sterile coveralls in the facility's prep room amongst sterile garb staged for use in production. B) A textured wall panel, approximately 4' x 18" in size, was observed on the wall in ISO 8 room Anteroom <Redacted B4> where all bulk formulation is performed.

Your outsourcing facility compounds drug products using bulk drug substances that cannot be used in compounding under section 5038 because they (a) are not used to compound drug products that appear on the drug shortage list in effect under section 506E of the Act and (b) do not appear on a list developed by FDA of bulk drug substances for which there is a clinical need.

Specifically, Your facility compounded human drug products using semaglutide and tirzepatide bulk drug substance.

The responsibilities and procedures applicable to the quality control unit are not fully followed.

Specifically, 1A . Your Quality Unit failed to: a. Ensure the timely implementation of corrective and preventive actions for the observed dried and cracked <Redacted B4> settle plates used for environmental monitoring and then incubated in <Redacted B4> incubator. Please refer to OBSERVATION lB. b. Conduct adequate root-cause analyses for the ongoing Environmental Monitoring (EM) and Personnel Monitoring (PM) excursions. The Quality unit also failed to perform effectiveness checks on the implemented corrective and preventive actions, as evident by persistent fungal and bacterial recoveries despite implementing corrective actions in the clean room areas. Please refer to OBSERVATION 2 and OBSERVATION 3. c. Investigate the root cause of visual inspection failure during initial 100% inspection before proceeding to secondary /tertiary inspection of the filled syringes. Please refer to OBSERVATION 4. d . Evaluate air flow patterns under dynamic conditions in all ISO 5 classified BSC cabinets in the clean room. Please refer to OBSERVATION 3.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.

Specifically, 2A. Your firm's environmental monitoring program failed to prevent or adequately address repeated fungal (mold) contamination in ISO Class 7 and ISO Class 8 classified areas within the same cleanroom <Redacted B4> that support aseptic compounding operations conducted in ISO Class 5 Primary Engineering Controls. The environmental monitoring data collected between July 2025 and April 2026 document at least nineteen (19) separate fungal excursion events across ISO 8 rooms (Rooms <Redacted B4> representing a recurring and unresolved pattern of mold contamination in the classified cleamoom environment supporting aseptic compounding operations. The following is the list of nineteen (19) documented fungal contamination events in the clean room area: Investigation# Date Opened I Date Closed I Room / ISO Class CFU Count Organism(s) Identified I I I I AM ENDMENT2

Production personnel were not practicing good sanitation and health habits.

Specifically, Your firm failed to establish and maintain adequate controls to prevent repeated objectionable Inicroorganism recoveries during personnel monitoring (PM) activities in ISO Class 5 and ISO Class 7 classified areas. Environmental monitoring records document six (6) personnel monitoring excursion events involving bacterial contamination from personnel gowning samples ( chest, forehead, forearm) and fingertip samples collected between April 2025 and February 2026.

There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

Specifically, Your firm failed to conduct, or document, an investigation into the root cause of visual inspection failures prior to proceeding with secondary and/or tertiary inspections. A review of ophthalmic lot visual inspection records spanning from March 2025 through early 2026 identified forty-four (44) lots in which the firm proceeded directly to secondary inspection following a primary visual inspection failure which was characterized by major reject rates exceeding the <Redacted B4> acceptance limit and/or major defects found at the primary AQL stage. There was no documented investigation and root cause analysis into the source and cause of these recurring defect types prior to re inspection.