This week's 6 FDA warning letters all touch drug manufacturing, laboratories, or clinical practice, with sterile and aseptic manufacturing running as the dominant theme across multiple letters. 21 CFR 211.22 (quality control unit responsibilities) was cited more than usual, appearing in 5 records, as were 21 CFR 211.166 (stability testing), 211.113 (microbiological contamination control), 211.192 (production record review), 211.194 (laboratory records), and 211.84 (component testing). Data integrity concerns appear at Eurofins SF Analytical Laboratories, Inc. SCA Pharmaceuticals, LLC received a warning letter despite at least 5 prior Form 483 observation reports. Jiangmen Shuizirun Sanitary Articles Co., Ltd. is connected to an import alert.
6FDA warning letters, all on drug manufacturing, laboratories and clinical practice
4EU/EEA GMP non-compliance reports
Companies to note
Chosen by fixed rules, shown as the reason: an earlier enforcement record for the same firm, an import alert, data integrity, sterile manufacturing, or Part 11.
Eurofins SF Analytical Laboratories, Inc.FDA warning letter
raises data integrity
Hanlim Pharm Co., Ltd.FDA warning letter
sterile or aseptic manufacturing
Jiangmen Shuizirun Sanitary Articles Co., Ltd.FDA warning letter
mentions an import alertsterile or aseptic manufacturing
SCA Pharmaceuticals, LLCFDA warning letter
earlier: 483, Mar 13, 2026483, Oct 30, 2025483, Dec 20, 20242 moresterile or aseptic manufacturing
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting4 × EMA GMP non-compliance report
raises data integritysterile or aseptic manufacturing
Regulations cited most
Records citing each 21 CFR section this week, and cumulative, prior 12 weeks.
| 21 CFR section | This week | Cumulative, prior 12 weeks |
|---|
| 211.22 Responsibilities of quality control unit | 5 | 18 |
|---|
| 211.166 Stability testing | 3 | 8 |
|---|
| 211.113 Control of microbiological contamination | 3 | 13 |
|---|
| 211.192 Production record review | 3 | 13 |
|---|
| 211.194 Laboratory records | 2 | 3 |
|---|
| 211.84 Testing and approval or rejection of components, drug product containers, and closures | 2 | 9 |
|---|
| 211.42 Design and construction features | 2 | 14 |
|---|
| 211.130 Packaging and labeling operations | 1 | 0 |
|---|
FD&C Act provisions cited: 501(a)(2)(B) (5), 505(a) (2), 801(a)(3) (2), 201(g)(1) (1), 201(p) (1), 301(a) (1).
FDA warning letters: drug manufacturing, laboratories and clinical practice
An FDA warning letter states what FDA believes a firm has done wrong. A pre-enforcement notice: no legal effect of its own, and the firm is asked to respond.
Warning letter
Eurofins SF Analytical Laboratories, Inc.
FDA's letter cites violations at a contract testing laboratory covering microbiological data integrity, deviation investigations, and quality unit oversight under 21 CFR 211.194, 211.192, and 211.22. Analysts were found "selectively recording test results" — omitting too-numerous-to-count membrane filter results and recording colonies as 0 CFU — while cracked, desiccated plates were used without investigation. FDA recommends engaging a qualified CGMP consultant and requires a written response within 15 business days.
CDER · issued October 6, 2026 · posted October 13, 2026 · CGMP/Finished Pharmaceuticals/Adulterated
211.192211.194211.22
Read the letter →
Warning letter
Lovelace Biomedical Research Institute
FDA's letter cites failures by the quality assurance unit to ensure that final study reports for two nonclinical investigational drug studies accurately reflected raw data, as required by 21 CFR 58.35(b)(6). Omitted data included abnormal cageside clinical observations for dozens of animals and individual dosing incidents such as catheter pull-outs, tissue infiltration, and irregular breathing during aerosol exposure. FDA found the facility's corrective action response inadequate and requires a written reply within 15 business days.
CDER · issued October 6, 2026 · posted October 13, 2026 · Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Read the letter →
Warning letter
Silgan Dispensing Systems
FDA's letter cites CGMP violations at a Spokane, Washington facility that contract manufactures non-sterile OTC drug products, including failures to properly investigate out-of-specification microbiological results under 21 CFR 211.192—specifically, invalidating failing yeast and mold counts by averaging results, a practice FDA says "obscures the detection of non-uniform microbiological contamination." FDA also cites quality unit failures under 21 CFR 211.22, 211.84, 211.166, and 211.180, including absent stability study reports since 2020, and identifies certain products as unapproved new drugs; a Class I recall by a customer for potential fungal contamination is noted.
CDER · issued October 5, 2026 · posted October 13, 2026 · CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
211.166211.180211.192211.22211.84
Read the letter →
Warning letter
Hanlim Pharm Co., Ltd.
FDA's letter cites violations observed during an April 2026 inspection of the firm's sterile drug manufacturing facility, covering aseptic practices, cleanroom design, equipment sterilization, environmental monitoring, and visual inspection. Inspectors found operators "repeatedly broke first air by reaching their arms, torsos, and heads over open sterile tubes" during interventions, smoke studies revealed unprotected critical zones, and container-closure contact surfaces were wiped with disinfectant rather than sterilized. FDA says the firm's corrective responses lacked sufficient detail and that failure to address these violations may result in seizure or injunction.
CDER · issued October 2, 2026 · posted October 13, 2026 · CGMP/Finished Pharmaceuticals/Adulterated
211.110211.113211.166211.194211.22211.42
Read the letter →
Warning letter
Jiangmen Shuizirun Sanitary Articles Co., Ltd.
FDA's letter cites multiple CGMP violations found during a November 2025 inspection of this Chinese over-the-counter drug manufacturer, including products labeled "sterile" that undergo no sterility testing, failure to perform adequate identity and hazardous-impurity testing on incoming components under 21 CFR 211.84, and a quality unit that did not fulfill its oversight responsibilities under 21 CFR 211.22, 211.100, 211.113, 211.130, 211.165, and 211.166. FDA says the firm did not respond to contact attempts in early 2026 regarding a potential recall and recommends removing sterile-labeled products currently in U.S. distribution.
CDER · issued September 23, 2026 · posted October 13, 2026 · CGMP/Finished Pharmaceuticals/Adulterated
211.100211.113211.130211.165211.166211.22211.84
Read the letter →
Warning letter
SCA Pharmaceuticals, LLC
FDA's letter cites insanitary conditions and CGMP violations at this 503B outsourcing facility producing sterile compounded drug products, including Fentanyl Citrate, Bupivacaine HCl, Methadone HCl, and Ketamine HCl. Deficiencies cited under 21 CFR 211.113, 211.42, 211.192, 211.160, and 211.22 include inadequate ISO 5 area certification, poor aseptic technique by compounding personnel, deficient environmental monitoring, and failure to retain production video recordings needed for contamination investigations. FDA says some proposed corrective actions remain inadequately supported by documentation.
CDER · issued September 14, 2026 · posted October 13, 2026 · CGMP/Finished Pharmaceuticals/Adulterated
200.10210.1211.113211.160211.192211.22211.42
Read the letter →
EU/EEA GMP non-compliance reports
A GMP non-compliance report records a decision a national competent authority has already taken, and states the consequence.
EU/EEA report × 4
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Health And Youth Care Inspectorate reports that an inspection conducted February 10–12 and April 22–23, 2026 found GMP non-compliance across sterile and non-sterile manufacturing of registered products, ATMPs, and investigational medicines, driven by one critical deficiency involving the release of batches that failed out-of-specification limits and a failed sterility test, plus seven major deficiencies covering aseptic controls, microbiological monitoring, the Pharmaceutical Quality System, computerized system validation, and documentation. As a consequence, GMP certificates NL/H 24/2051740A through NL/H 24/2051740D have been withdrawn, and a re-inspection is required before new certificates will be issued.
Health And Youth Care Inspectorate · site in the Netherlands · issued October 8, 2026
Read the report →
Health And Youth Care Inspectorate · site in the Netherlands · issued October 7, 2026
Read the report →
Health And Youth Care Inspectorate · site in the Netherlands · issued October 7, 2026
Read the report →
Health And Youth Care Inspectorate · site in the Netherlands · issued October 7, 2026
Read the report →
How this newsletter was made. Each record above was posted by FDA, or entered in the EudraGMDP register, during the week shown. The lists, counts and citations come straight from the records. The short summaries are written by AI from each record's own text, checked against that text, and reviewed by an editor before sending. Read the source before relying on a summary.
What each newsletter covers. Warning letters from FDA's drug (CDER), biologics (CBER) and device (CDRH) centers; Form 483s and inspection reports FDA posts in its FOIA Electronic Reading Room; and GMP non-compliance reports entered in the EU/EEA EudraGMDP register. Warning letters on food, tobacco and veterinary products are not covered, and letters to online sellers of unapproved drugs are listed by name only.
From Qualisera. RegLens holds FDA's CDER, CBER and CDRH warning letters, Form 483s and EU/EEA GMP non-compliance reports beside the regulations they cite, so you can ask what regulators have said about a clause and read the letters that say it. qualisera.ai
A warning letter, 483 or non-compliance report describes one firm at one time, and the firm's status may have changed since. Nothing here is legal or regulatory advice.
