This week brought 7 warning letters and 135 Form 483 inspectional observations. Data integrity surfaces in letters to Rohto Pharmaceutical Co., Ltd.—which also carries an import alert—and SnugZ USA, Inc., where analysts reportedly retested out-of-specification samples without justification until passing results were obtained. Olympus Medical Systems Corporation received a warning letter despite 2 earlier warning letters, with open CAPAs cited across 6 facilities. Among CFR sections cited more than usual this week: 21 CFR 211.192 (production record review), 211.67 (equipment cleaning and maintenance), 211.160 (general requirements), and 211.84 (component testing and approval).
Companies to note
Chosen by fixed rules, shown as the reason: an earlier enforcement record for the same firm, an import alert, data integrity, artificial intelligence, or Part 11.
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 |
|---|
| 211.192 Production record review | 3 | 14 |
|---|
| 211.67 Equipment cleaning and maintenance | 2 | 5 |
|---|
| 211.160 General requirements | 2 | 5 |
|---|
| 211.84 Testing and approval or rejection of components, drug product containers, and closures | 2 | 11 |
|---|
| 211.113 Control of microbiological contamination | 2 | 15 |
|---|
| 211.22 Responsibilities of quality control unit | 2 | 22 |
|---|
| 211.63 Equipment design, size, and location | 1 | 1 |
|---|
| 211.180 General requirements | 1 | 1 |
|---|
FD&C Act provisions cited: 501(a)(2)(B) (5), 201(h) (2), 301(a) (2), 801(a)(3) (2), 201(g)(1) (1), 201(i) (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
Rohto Pharmaceutical Co., Ltd.
FDA's letter cites systemic data falsification at a Vietnam-based manufacturing facility producing over-the-counter topical ophthalmic drug products, including falsified environmental monitoring, personnel monitoring, and cleaning records under 21 CFR 211.194(a) and 211.67(a). FDA also cites poor aseptic practices, equipment design deficiencies, and inadequate airflow under 21 CFR 211.113(b) and 211.63. Additionally, FDA says seven "ROHTO® Cooling Eye Drops" product lines are unapproved new drugs and misbranded, and the firm has suspended U.S. production and distribution pending remediation.
CDER · issued October 14, 2026 · posted October 20, 2026 · sterile or aseptic · CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
211.113211.192211.194211.63211.67
Read the letter →
Warning letter
FDA's letter cites contamination of finished drug products manufactured at the firm's Phoenix, Arizona facility, finding that shared equipment and manufacturing areas led to undeclared ingredient cross-contamination detected across all sampled lots. FDA says the products are adulterated under sections 501(a)(2)(B) and 501(a)(2)(A) of the FD&C Act, noting a prior 2025 recall for similar contamination and a January 2026 warning letter addressing the same cross-contamination risks. The firm verbally committed to halt manufacturing and distribution and conduct a voluntary recall of all affected products.
CDER · issued October 1, 2026 · posted October 20, 2026 · CGMP/Finished Pharmaceuticals/Adulterated
Read the letter →
Warning letter
Zhejiang Gaorong Cosmetic Co., Ltd.
FDA's letter cites CGMP violations at this OTC drug manufacturing facility, including failure under 21 CFR 211.84 to conduct adequate identity and impurity testing on incoming components — some at high risk for contamination that has caused "lethal poisoning incidents in humans worldwide" — and relying solely on supplier certificates of analysis. FDA also says the quality unit failed its oversight duties under 21 CFR 211.22, including incomplete batch records and unsupported product expiry dates. FDA placed the firm's drugs on Import Alert 66-40 and requires a written response within 15 business days.
CDER · issued October 1, 2026 · posted October 20, 2026 · CGMP/Finished Pharmaceuticals/Adulterated
211.22211.84
Read the letter →
Warning letter
Baxter International Inc.
FDA's letter cites violations at a Round Lake, Illinois injectable drug manufacturing facility, including repeated detection of cephalosporin contamination on the non-beta-lactam side of the building and inadequate environmental monitoring under 21 CFR 211.42, as well as poorly validated sterilization processes with recurring biological indicator growth and insufficient aseptic process simulations under 21 CFR 211.113(b). FDA says contaminated product poses a "serious risk to patient safety," and the letter demands independent facility risk assessments, expanded environmental monitoring, full contamination investigations, and detailed remediation plans with timelines.
CDER · issued September 29, 2026 · posted October 20, 2026 · sterile or aseptic · CGMP/Finished Pharmaceuticals/Adulterated
211.113211.160211.192211.42
Read the letter →
Warning letter
SnugZ USA, Inc.
FDA's letter cites CGMP violations found during an April–May 2026 inspection of the firm's West Jordan, Utah facility, which manufactures OTC drug products distributed primarily as promotional items. FDA says the firm repeatedly retested out-of-specification chemical and microbiological samples, preparing new samples "without justification until your analysts obtained passing results," then released product without proper investigations, and conducted complaint investigations lacking root cause analysis or CAPA. The letter also cites failures under 21 CFR 211.84 for inadequate incoming component identity testing, and warns that failure to address violations may result in seizure or injunction.
CDER · issued September 28, 2026 · posted October 20, 2026 · CGMP/Finished Pharmaceuticals/Adulterated
211.160211.180211.188211.192211.22211.67211.84
Read the letter →
FDA warning letters: biologics
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
Tides Medical LLC
FDA's letter cites the distribution of APLICOR 3D — described as "a hyper-personalized 3D bioprinting platform" that uses a patient's own adipose tissue to create customized grafts for acute and chronic wounds — without an approved PMA or IDE, rendering it adulterated and misbranded. The firm had claimed the device was a Class I liquid medication dispenser exempt under 21 CFR 880.6430, but FDA says its intended uses exceed the limitations of 21 CFR 880.9. FDA requests the firm cease commercial distribution and respond within 15 business days, warning that seizure, injunction, or civil money penalties may follow.
CBER · issued October 6, 2026 · posted October 20, 2026 · Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
880.6430880.9
Read the letter →
FDA warning letters: medical devices
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
Olympus Medical Systems Corporation
FDA's letter cites Quality System Regulation violations across six manufacturing facilities producing surgical and endotherapy devices, including insufflators, sphincterotomes, cystoscopes, bronchoscopes, and endoscopic clips. Findings under 21 CFR 820.30, 820.90, and related sections include failures to validate device designs under actual use conditions, unaddressed catastrophic hazards such as air embolism and patient death linked to the UHI-4 insufflator, and rework of nonconforming Vizishot 2 FLEX devices without identifying root cause. FDA says the devices are adulterated and that corrective actions across multiple open CAPAs remain incomplete, with effectiveness not yet demonstrated.
CDRH · issued October 7, 2026 · posted October 20, 2026 · CGMP/QSR/Medical Devices/Adulterated
803.12803.50803.52820.100820.198820.30820.50820.75820.80820.90
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
Glukem Biocare Private Limited
Malta Medicines Authority reports that an inspection on 2026-09-15 found GMP non-compliance at this Indian manufacturer of non-sterile intermediates (pellets) and quality control testing operations. A critical deficiency involved "an observed pool of liquid and residue in a section of the inlet air plenum of a fully cleaned FBC," along with eleven major findings covering batch records, process validation, cleaning validation, and other controls. As a consequence, marketing authorisations are to be revoked, and no product batches from the site should be released to EEA markets.
Malta Medicines Authority · site in India · issued October 16, 2026 · sterile or aseptic
Read the report →
An FDA Form 483 lists what an FDA investigator observed at the close of an inspection. The form states that these "are inspectional observations, and do not represent a final Agency determination regarding your compliance". It cites no regulation.
Summarized here: companies to note, then the most recent inspections, 1 in all. Every one is in the table at the end.
Form 483
WS Audiology USA Inc.
The 483 lists one observation: the firm's complaint handling procedure (Doc. ID GLOBAL\_SOP\_QM\_004, Version 14, dated 2/15/2025) does not include adequately written instructions specifying how employees must investigate and document complaints. The investigator observed that the procedure fails to identify all internal records — such as device history records and receiving inspection test results — that should be reviewed during a complaint investigation, and does not require documenting the results of those reviews in complaint records.
inspection ended October 20, 2025 · posted October 19, 2026 · Manufacturer
Read the 483 →
Show all 135
135 records, by firm. Each firm name links to FDA's copy.
Added late by FDA
FDA dated these before this week, but they were not yet on its site when that week's newsletter was prepared.
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.
