This week's 8 warning letters lean heavily on unapproved-drug and labeling issues, with 21 CFR 201.5 and 21 CFR 201.115 both cited above their usual pace — each appearing in 4 records. On the manufacturing side, 21 CFR 211.84, 21 CFR 211.100, and 21 CFR 211.22 all ran above usual as well, signaling recurring gaps in component testing, written procedures, and quality-unit oversight. Purolea Cosmetics Lab's warning letter faults the firm for using AI agents to write its specifications, procedures and master production records without reviewing what they produced. Pure Indulgence Aesthetics received a warning letter after having already been the subject of a Form 483 — investigators' observations — from a prior visit.
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 |
|---|
| 201.5 Drugs; adequate directions for use | 4 | 3 |
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| 201.115 New drugs or new animal drugs | 4 | 8 |
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| 211.84 Testing and approval or rejection of components, drug product containers, and closures | 2 | 6 |
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| 211.100 Written procedures; deviations | 2 | 10 |
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| 211.22 Responsibilities of quality control unit | 2 | 11 |
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| 201.10 Drugs; statement of ingredients | 1 | 0 |
|---|
| 201.66 Format and content requirements for over-the-counter (OTC) drug product labeling | 1 | 0 |
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| 207.29 What are the requirements for reviewing and updating registration information? | 1 | 0 |
|---|
FD&C Act provisions cited: 201(p) (7), 301(d) (7), 505 (7), 505(a) (7), 301(a) (6), 201(g) (4).
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
Medical Products Laboratories, Inc.
FDA's letter cites violations of 21 CFR 211.113, 211.100, and 211.192 at a Philadelphia finished-drug manufacturing facility, covering prescription and OTC topical products including hydroquinone, sodium sulfacetamide, and salicylic acid formulations. FDA says the firm released batches after "too numerous to count" microbial contamination using an unvalidated treatment protocol, lacked adequate process validation, and failed to thoroughly investigate out-of-specification microbiological and stability results. The letter also identifies several products, including Plexion-branded items, as unapproved new drugs and requires comprehensive remediation, risk assessments, and potential recalls.
CDER · issued April 9, 2026 · posted April 14, 2026 · CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
211.100211.113211.166211.192
Read the letter →
Warning letter
Purolea Cosmetics Lab
The firm told FDA investigators it used AI agents to write its drug product specifications, procedures and master production records. FDA says AI-generated documents must be reviewed for accuracy and CGMP compliance; not doing so violates 21 CFR 211.22(c). Told it had not validated its process (21 CFR 211.100), the firm replied that the AI agent "never told you it was required." The letter also cites missing microbiological testing (21 CFR 211.165), component testing (21 CFR 211.84), and insects and filth in the facility. Production has stopped; future AI output must be cleared by the quality unit.
CDER · issued April 2, 2026 · posted April 14, 2026 · CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
207.29207.57211.100211.165211.22211.84
Read the letter →
Other FDA warning letters
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
Chemco Corporation
FDA's letter cites CGMP violations at a Miami Lakes OTC drug manufacturing facility, including failure to clean shared equipment (21 CFR 211.67), inadequate identity testing of components for potentially lethal contaminants (21 CFR 211.84), and a quality unit that failed to ensure compliance (21 CFR 211.22). Several products — including "PRO Nail FUNGUS KILLER" — are also cited as unapproved new drugs or misbranded under multiple FD&C Act provisions. FDA requires comprehensive retrospective assessments, CAPAs, contamination risk evaluations, and component testing results within 30 days.
CDER · issued April 7, 2026 · posted April 14, 2026 · Nonprescription/OTC
201.10201.66207.77211.22211.67211.84310.545
Read the letter →
Warning letter
Pure Indulgence Aesthetics
FDA's letter cites Drug Supply Chain Security Act violations at a Texas medical spa that dispensed far more product labeled as Botox® than purchase records from the authorized manufacturer could account for, indicating sourcing from unauthorized trading partners in violation of FD&C Act Section 582(d)(3). Investigators also found an unlabeled vial in the facility's trash that laboratory analysis confirmed contained botulinum neurotoxin type A, lacking any required product identifier under Section 582(d)(2). The firm must respond within 15 working days with corrective steps or face possible seizure or injunction.
CDER · issued April 1, 2026 · posted April 9, 2026 · Drug Supply Chain Security Act (DSCSA) Violations
Read the letter →
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.
Form 483
SMS Pharmaceutical Limited - Unit VII
The 483 lists an observation that the firm's extraneous matter testing procedure was not followed correctly: rather than converting particle counts to a per-unit basis to determine pass/fail, results were reported in a way that made a failing batch appear to pass. The investigator observed that one batch of an active pharmaceutical ingredient USP, which would have yielded a failing particle count under the established specification, was nonetheless dispatched to the U.S. market.
inspection ended December 12, 2025 · posted April 8, 2026 · API (animal origin) Manufacturer
Read the 483 →
Show all 3
3 records, by firm. Each firm name links to FDA's copy.
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.
