글로벌 규제 모니터
2026년 8월 3주차 규제뉴스

Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.

Specifically, the quality unit failed to identify appropriate root causes and to implement corrections to reduce and adequately address the number of complaints for ©@® drug product, oa For example, Since 2024, the site received approximately 845 complaints related to9) drug product batches distributed to the US. The complaint review indicated significant number (approximately 50%) of the complaints were related toy) _ malfunction such as ae )(4) ©©® as follows

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.

Specifically, in the video for airflow visualization studies ofthe aseptic _ filling line used to produce all drug products (VALQ - 8900 - L3-2b, performed on August 1 Sth, 2023), the qualification of the 9)4» @@ intervention to add unopened stopped bags showed that airflow from the 4, _ filling unit into the stopper loading station causes a void over the unopened stopper bags, preventing first-pass airflow from reaching the bags while the, 4» The stopper bags are not further disinfected before they are opened tO &

Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure drug products conform to appropriate standards of identity, strength, quality, and purity.

Specifically, requalification for employees performing 100% visual inspection for particulates on (uy Ba is performed ome after each employee has completed inspection of O@ despite the fact that the employees will inspect up to 4)» during 4«) There has been no initial or requalification afterg, 45 ) inspection to demonstrate that the employees can perform the operation adequately 9)

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

Specifically, the quality unit failed to ensure environmental monitoring trend reports are generated as required under SOP-0509, Trending of environmental monitoring data. For example,

Contamination was observed in your production area and areas adjacent to production areas.

Specifically, A) A pallet of used compounding equipment was observed in the non-classified Amoxicillin storage room. Items on this pallet included, but were not limited to, used process <Redacted B4> which were coated with yellow residue, metal fittings, and hoses. All equipment on this pallet appeared to be coated with a layer of white powder. Your staff stated that this pallet of used equipment had been present in this location for approximately 1.5 to 2 years. This pallet is located immediately adjacent to the door leading to Amoxicillin Room <Redacted B4> where finished product compounding and packaging of Amoxicillin products takes place. B) Widespread and extensive damage was observed on the painted drywall walls in the Amoxicillin processing area. This damage included an approximately 6-inch long and 3-inch deep hole punched in a wall from the handle of an over-extended door, multiple scrapes in paint and drywall ranging from 1 to 6 inches, and broken floor ceramic molding. This damage was noted approximately 10 feet from the chute where Amoxicillin capsules were <Redacted B4> openly into <Redacted B4> container <Redacted B4> an <Redacted B4> C) Black stains were observed on

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

Specifically, Aseptic process simulations (media fills), along with the governing procedure SOP CR-02 -Aseptic Technique & Gloved Fingertip Thumb Test-are deficient in that they do not simulate the finished product container size, number of units, or worst-case conditions that may arise during compounding activities. Media fills conducted by your <Redacted B4> simulate aspetic processes utilized <Redacted B4> which contain a total of <Redacted B4> IV bags and associated equipment. <Redacted B4> is used by each sterile compounding technician as part pf their <Redacted B4> aseptic process simulation evaluation. During a review of your sterile compounding records for March 4, 2026, a lot size <Redacted B4> 2000 ml bags of Iron 20% (200 mg/ml) was noted in the compounding of Lot #V20030526 on 05MAR2026. This batch was compounded to fulfill Rx <Redacted B4> and shipped to your customer on 3/11/2026. Additional batch sizes on <Redacted B4> an <Redacted B4> 2000 mL bags were also noted in compounding records from 04MAR2026 -10MAR2026. Additionally, Form CR-37 -Periodic Cleanroom Aseptic Evaluation -which is used to <Redacted B4> qualify your sterile technicians, does not document the amou

Deviation from the procedural requirements of a decree of injunction.

Failure to investigate all out of specification test results.

Specifically, a review of(b) (4) test results from March 2024 to February 2026 revealed four (4) instances where your firm received an out of specification test result for endotoxins. Your firm has no documentation to show that these out of specification test results were investigated nor did you perform any product impact assessment. Per MIDL-SOP-307 (b) (4) , effective January 1, 2024, the specification for endotoxin is (6) (4) EU/mL. * Sample from © system collected 05/29/2024 - test result was 0.430 EU/mL * Sample from© system collected 09/25/2024 - test result was 1.508 EU/mL * Sample from© system — QC Laboratory collected 09/25/2024 - test result was 0.439 EU/mL * Sample from© system — QC Laboratory collected 03/3 1/2025 - test result was 17.589 EU/mL * Sample from © system collected 05/27/2025 - test result was 0.418 EU/mL In addition, several of the lab reports for the testing of the (b) (4) _ indicate that the sample for endotoxin testing was received outside of the recommended temperature range. The laboratory report does not state the temperature the samples were received at nor does it state what the recommended temperature range is. There is no evaluation of this issue

Failure of the Quality Unit to fulfill its oversight responsibilities.

Specifically, a) CAPAs are not fully documented in accordance with your established procedure entitled Corrective and Preventative Actions (MIDL-SOP-124) effective January 1, 2024; they also are not closed out in a timely manner. For example: * CP25-014 (initiated 8/15/2025), CP25-010 (initiated 7/01/2025), CP25-019 (initiated 11/17/2025), CP24-12 (initiated 10/11/2024), and CP24-13 (initiated 9/24/204), either lack or have insufficient documentation of an effectiveness check. * CP24-12, CP24-13 and CP25-019 have not been finalized and signed off as completed or reviewed by quality. b) Your firm does not have written procedures for the issuance, use and reconciliation of loose-leaf forms used for documentation of manufacturing (e.g. batch record) and laboratory testing. Examples of these forms include: - All forms and documents that are part ofthe batch record * Form 239A Reagent/Solution Preparation Log * Form 120A Label Control Form * Form 121A Label Issuance ¢ Form 112B ©)@) Pre-Shipment Review Log ¢ Form 133D Total Unacceptable (b) (4) Count c) There is a failure to review and approve all quality-related documents. The analytical testing lab books (data collection form) used fo

Your firm failed to conduct an annual product quality review of your API.

During the current inspection ofyour facility we observed that you had not conducted your 2024 annual product quality review for your API (b) (4) , USP. On August 6, 2025, your firm initiated a deviation report however, no content was provided in the report explaining why the 2024 review had not been completed or when it would be finalized. The deviation is still open.

Failure to perform testing of the (b) (4) used in production and in the QC Laboratory.