FDA Cites Medical Products Laboratories, Inc. in 2026-04-09 Warning Letter — CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
Letter issued · posted to fda.gov .
Subject as published: CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
TL;DR
Here's the summary: FDA issued a Warning Letter to Medical Products Laboratories, Inc. on 2026-04-09 citing: CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug. Full letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/medical-products-laboratories-inc-721916-04092026
Argus analysis
Medical Products Laboratories, Inc. (MARCS-CMS 721916, FEI 2513595) received an FDA Warning Letter dated April 9, 2026 from the Center for Drug Evaluation and Research (CDER). The letter cites: CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug. FDA posts Warning Letters to fda.gov after an internal review period; this one was made public on April 14, 2026.
CGMP citations typically reference 21 CFR Part 211 (finished pharmaceuticals) or Part 111 (dietary supplements), covering subjects such as identity testing of incoming components, validated cleaning procedures, batch-failure investigations, and stability program design. Repeat or systemic findings are what typically drive FDA toward import alert or consent decree escalation.
FDA Warning Letters typically specify a 15-working-day response window for the recipient to detail corrective actions. Compliance teams at peer companies in the same CGMP (Current Good Manufacturing Practice) category commonly use a newly published letter as a prompt to re-check their own procedures against the same citation, and to watch fda.gov for a close-out letter confirming the cited firm's corrective action was accepted — or, absent one, for escalation to import alert, injunction, or product seizure.
Severity context
Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
Regulatory background
CGMP citations typically reference 21 CFR Part 211 (drugs) or 21 CFR Part 600 (biologics). Common subjects include identity testing of incoming components (211.84), validated cleaning procedures (211.67), and stability program design (211.166).
What peer compliance teams typically do next
Most compliance officers at peer companies use a Warning Letter against a named entity as a checklist for their own CAPA program. Common steps: pull the verbatim FDA letter; map each cited 21 CFR section against the team’s SOP library; confirm CAPA coverage; brief the QMR (Quality Management Review) on whether the cited subject matter is in scope for the next internal audit. The 15-business-day response window applies to the cited entity, not to peers — but a documented internal review against the cited subjects is what regulators expect to see if a peer is later inspected on the same topic.
Excerpt from the FDA Warning Letter (public domain, 17 USC §105)
WARNING LETTER Medical Products Laboratories, Inc. MARCS-CMS 721916 — April 09, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Elliot Stone Recipient Title President/CEO Medical Products Laboratories, Inc. 9990 Global Road Philadelphia , PA 19115 United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States Warning Letter 320-26-61 April 9, 2026 Dear Mr. Stone: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Medical Products Laboratories, Inc., FEI 2513595, at 9990 Global Road, Philadelphia, from September 29 to October 16, 2025. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211). Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B). Your firm manufactures and is responsible for introducing or delivering for introduction into interstate commerce in the United States products that are unapproved new drugs in violation of sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. Sections 331(d) and 355(a), including but not limited to: Hydro-Q 4% Gel (hydroquinone 4%); Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension; Sodium Sulfacetamide 9% and Sulfur 4% Wash; Sodium Sulfacetamide 9.8% Shampoo; Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser; Sodium Sulfacetamide 9.8% and Sulfur 4.8% Lotion; Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cream; Sodium Sulfacetamide 10% and Sulfur 5% Cleanser; Sodium Sulfacetamide 10% Wash; Salicylic Acid 28.5% Solution; Plexion Shampoo (sodium sulfacetamide 9.8%); Plexion Lotion (sodium sulfacetamide 9.8% and sulfur 4.8%), Plexion Cream (sodium sulfacetamide 9.8% and sulfur 4.8%) as prescription drug products. Based on our review, these products are unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. Section 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. Sections 331(d) and 355(a). We reviewed your November 6, 2025 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. During our inspection, our investigators observed specific violations including, but not limited to, the following. CGMP Violations 1. Your firm failed to establish and follow appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile (21 CFR 211.113(a)). Microbiological Results in Finished Drug Product and (b)(4) …
Excerpt only. The full verbatim Warning Letter is the source of truth — always read the original before regulatory decisions.
The verbatim FDA Warning Letter is the source of truth. Always read the original before acting on any analysis or summary on this page.
Read the full letter on fda.gov ↗Frequently asked questions
- What FDA violations was Medical Products Laboratories, Inc. cited for?
- The FDA Warning Letter to Medical Products Laboratories, Inc. (issuing office: Center for Drug Evaluation and Research (CDER)) cites: CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug. Classification: CGMP — Current Good Manufacturing Practice.
- When did FDA issue the warning letter to Medical Products Laboratories, Inc.?
- FDA issued the letter (MARCS-CMS 721916) on 2026-04-09 and posted it publicly on fda.gov on 2026-04-14.
- Is the FDA warning letter to Medical Products Laboratories, Inc. publicly available?
- Yes. The full verbatim letter is published at fda.gov. Argus HQ links directly to the source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/medical-products-laboratories-inc-721916-04092026.
- What does a "critical" severity rating mean for this letter?
- Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
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methodology
The analysis above is produced by Anthropic Claude Haiku 4.5 against the verbatim FDA Warning Letter excerpt and is brand-voice lint-checked before publish. The TL;DR is the same summary that ships in the customer email digest. Severity is auto-classified by Argus from the subject string and letter body using rules documented in lib/ingestion/fda-warning-letters.ts.
Argus HQ is informational only. Summaries and analyses are AI-generated and may contain errors, misclassifications, or omissions. Verify against the FDA source URL above. Argus HQ is not a law firm, accounting firm, or regulatory agency, and provides no legal, accounting, financial, medical, or regulatory advice.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Cites Medical Products Laboratories, Inc. in 2026-04-09 Warning Letter — CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-medical-products-laboratories-inc-2026-04-09-cgmp
"FDA Cites Medical Products Laboratories, Inc. in 2026-04-09 Warning Letter — CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-medical-products-laboratories-inc-2026-04-09-cgmp.
Argus HQ Research. "FDA Cites Medical Products Laboratories, Inc. in 2026-04-09 Warning Letter — CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-medical-products-laboratories-inc-2026-04-09-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_medical_products_laboratories_inc_2026_04_09_cgmp_2026,
title = {FDA Cites Medical Products Laboratories, Inc. in 2026-04-09 Warning Letter — CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-medical-products-laboratories-inc-2026-04-09-cgmp},
note = {Accessed: July 13, 2026}
}