Global Regulatory Monitor
Regulatory News, Week 1 · 2026/7

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

Specifically, A. The written procedure, SOP ML Wl-001-04, titled' on-Sterile Compounding Area", Revision 2.0, is not consistently followed. As specified in Section 3.9.1, the minimum garb required to enter the compounding area includes a reusable lab coat, shoe covers, Hair/bear net, and N95 mask or respirator. When gowned, they must remain within the compounding area and may only be reused during the <Redacted B4>. However, employees were observed donning gloves and shoe covers upon entry through the back door, proceeding through the compounding area to the basement to put on their gowns, and then re-entering the compounding area. B. The written procedure, SOP J\1L WI-001-05, titled "Non-Sterile HD Compounding Area," Revision 2.0, is not always followed. As specified in Section 3.3, non-sterile hazardous drug (HD) compounding and HD storage must occur in a Containment Segregated Compounding Area (C-SEC) that is separate from non-HD compounding and/or non-HD storage. However, on 7/15/2025, a pharmacy technician was observed filling Methimazole (6mL pen) 2.5mg/0.lmL, Transdermal, Lot <Redacted B4> quantity <Redacted B4>, in the non-HD compounding area. C. The written procedure, SOP

The master production and control records are not followed.

Batch production and control records do not include complete information relating to the production and control of each batch.

Specifically, Your firm's batch records do not include documentation and/or complete documentation of each significant step in the production of drug products. For example, Your firm compounds Methimazole 2.5mg/0. l mL Transdermal and fills it into a <Redacted B4> syringe. The CJ syringe is then used to fill Metbimazole 2.5mg/0. lmL Transdermal into 1mL, 3mL, 6mL, and 9mL pens. The following was observed upon review of the manufacturing batch record for Methimazol(6mL pen) 2.5mg/0.lmL Transdermal, Lot <Redacted B4> quantity <Redacted B4> manufactured on <Redacted B4> e

Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture processing, packing or holding of a drug product.

Specifically, Your fi nn did not conduct an in-house efficacy study to verify the sporicidal product's label Instead, the adequacy of the cleaning agent for its intended use was determined based on a review of the efficacy study provided by the cleaning agent manufacturer.

Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.

Specific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis.

Specifically, A certificate of analysis from the supplier is accepted in lieu of testing of each component received. The firm currently neither is testing each component, including excipient and active ingredient, nor has a program to establish the reliability of the supplier.

There is no written testing program designed to assess the stability characteristics of drug products.

Specifically, Your firm does not have a written stability testing program to determine Beyond Use Dates (BUD) placed on all your drug product.

Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).

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 (21 CFR 211.42(c)(10).

Your firm failed to 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 (21 CFR 211.113(b)).

Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).

Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

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 (21 CFR 211.113(b)).

Your firm failed to maintain floors, walls, and ceilings of smooth, hard surfaces that are easily cleanable in aseptic processing areas and establish an adequate system for maintaining equipment used to control the aseptic conditions (21 CFR 211.42(c)(10)(i) and 211.42(c)(10)(vi)).

Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions (21 CFR 211.42(c)(10)(v)).

Your firm’s quality control unit failed to exercise its responsibility to ensure that drug products are manufactured in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity, as required by 21 CFR 211.22. Specifically, your quality unit failed to exercise its responsibility to ensure compliance with the following CGMP requirements: a. Failure to ensure that laboratory records include complete data derived from all tests necessary to assure compliance with established specifications and standards, as required by 21 CFR 211.194(a).

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

Specifically, your firm failed to adequately establish procedures to prevent microbiological contamination of drug products purporting to be sterile. For example, A. Your firm failed to adequately define and document the frequency of disinfection of a device used by technicians to pick items off the floor and place items into the trash in the ISO 7 cleanrooms. The device storage location has not been defined and documented. Currently, your technicians hang the device on the side of the <Redacted B4> used to hold drug components, utensils, drug product containers, and finished drug products. B. On 4/20/2026, during a site walk-through of your firm's ISO 7 classified aseptic processing cleanroom, I observed a "black residue" near the <Redacted B4> of each <Redacted B4> used to hold drug components, utensils, drug product containers, and finished drug products <Redacted B4> within all ISO 7 cleanrooms. Your firm's technicians failed to adequately clean and disinfect the entire <Redacted B4> located within the ISO 7 cleanroom. C. Your firm's dynamic ISO 5 LAFH/BSC smoke studies were found to be inadequate. Your firm's smoke studies within the ISO 5 LAFH/BSCs fail to adequately assess l

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, during a review of nonconforrmance number, IR-12512 (DEV-02984) documented on 14 Nov 2024, prior to compounding Fentanyl Citrate PF 50 mcg/mL Syringe, PC 700092168448, Lot 10138352, Expiry 02/12/2025 compounding in ISO 7 Cleanroom Suite 7, ISO 5 LAFH numbered <Redacted B4> your compounding technician found on the ISO 5 LAFH grate in front of the installed HEPA filter, a brown to black foreign residue contaminate, later within an investigation identified as a "Heat Resistant 6Sealant <Redacted B4>. The sealant is applied during the HEPA filter production as an exterior coating. Potential particulates from the degradation may become an airborne contaminate affecting first air quality used during aseptic processing of sterile drug product. The ISO 5 LAFH was removed from service, HEPA filter replaced by your firm's contract cleanroom re-certifier, re-certified, clean/disinfected, before returning to service in aseptically processing the product, Fentanyl Citrate PF 50 mcg/mL Syringe, PC 700092168448, Lot 10138352. Your firm was unable to provide sufficient documented evidence in support of the HEPA filter degradation start and if other potential ISO 5 LAFHs/BSCs in other

Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair.

Specifically, on 4/20/2026, during a site walk-through of your firm's ISO classified cleanroom, I observed paint peeling off Suite 3 ISO 8 Degowning Room wall comers and around the door frame exiting the ISO 7 Cleanroom