Warning Letter Record: Woodbine Products Company Inc. (2026-07-27) — CGMP/Finished Pharmaceuticals/Adulterated
Letter issued · posted to fda.gov .
Subject as published: CGMP/Finished Pharmaceuticals/Adulterated
TL;DR
Key takeaway: The FDA's Center for Drug Evaluation and Research (CDER) issued a warning letter to Woodbine Products Company Inc. (FEI 1519202), Medina, Ohio, on July 27, 2026, following an inspection February 9–13, 2026, citing CGMP violations for finished pharmaceuticals under 21 CFR parts 210–211. The firm failed to conduct required identity testing on incoming components (glycerin, propylene glycol, ethanol) used in OTC drug products, including failure to test for diethylene glycol/ethylene glycol contamination in high-risk ingredients and methanol contamination in ethanol, and used nonpharmaceutical-grade propylene glycol in manufacturing. The FDA stated the firm's March 5, 2026 response was inadequate because it lacked procedural controls, did not investigate the use of substandard components, and did not evaluate the impact on distributed products, requiring the firm to submit a comprehensive independent review of its material system, supplier qualification program with CAPA plan, and testing results on all components.
Argus analysis
# FDA Warning Letter Analysis: Woodbine Products Company Inc.
**Company and Violations**
Woodbine Products Company Inc., a finished pharmaceutical manufacturer located in Medina, Ohio (FEI 1519202), received a warning letter from the FDA's Center for Drug Evaluation and Research on July 27, 2026, following an inspection conducted February 9–13, 2026. The FDA determined that the company's over-the-counter drug products are adulterated due to significant Current Good Manufacturing Practice (CGMP) violations. The facility manufactures topical and alcohol-containing OTC drug products, yet failed to implement adequate component testing, particularly for materials at high contamination risk.
**Regulatory Citations and Implications**
The warning letter cites violations of 21 CFR parts 210 and 211, the foundational CGMP regulations governing finished pharmaceuticals. Specifically, 21 CFR 211.84(d)(1) requires identity testing of each component lot before use. The company failed to test incoming glycerin, propylene glycol, and ethanol—substances susceptible to contamination with diethylene glycol (DEG), ethylene glycol (EG), and methanol, all associated with fatal poisoning incidents globally. Additionally, 21 CFR 211.100(a) mandates written procedures ensuring drug identity, strength, quality, and purity; Woodbine lacked process validation studies and cleaning validation for shared equipment. These violations indicate inadequate supplier controls and insufficient manufacturing process documentation.
**Response Timeline and Industry Monitoring**
The company must respond with comprehensive remediation plans within 30 days for certain testing commitments (DEG/EG and alcohol impurity results). Compliance officers should monitor for follow-up FDA inspections, potential product recalls, and recall effectiveness checks. Industry peers manufacturing similar products—particularly those using glycerin or alcohol components—should anticipate increased FDA scrutiny of supplier qualification programs and incoming material testing procedures.
Severity context
High severity. Typically QSR / device CGMP, adulterated-drug, or significant labeling matters — usually drives a documented corrective and preventive action (CAPA) program.
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 Woodbine Products Company Inc. MARCS-CMS 729345 — July 27, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UPS Reference #: 320-26-107 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Stephen A. Kuzyk Jr. Recipient Title Secretary Treasurer Woodbine Products Company Inc. 915 W. Smith Road Medina , OH 44256-2446 United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States Warning Letter 320-26-107 July 27, 2026 Dear Mr. Kuzyk: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Woodbine Products Company Inc., FEI 1519202, at 915 W. Smith Road, Medina, from February 9 to 13, 2026. 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). We reviewed your March 5, 2026, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. During our inspection, our investigator observed specific violations including, but not limited to, the following. 1. Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)). Your firm manufactures over-the-counter (OTC) (b)(4) drug products such as (b)(4) and ethanol- (b)(4) . You failed to perform adequate identity testing on each shipment of each lot of incoming components (e.g., glycerin, propylene glycol, ethanol) used in the manufacture of your OTC (b)(4) drug products. Moreover, you used nonpharmaceutical-grade propylene glycol to manufacture your drug products. Products Containing Ingredients at Risk for Diethylene Glycol or Ethylene Glycol (DEG or EG) Contamination You also failed to adequately test your incoming components at high risk of DEG or EG contamination for identity before using them to manufacture your drug products. This includes, but is not limited to, testing of glycerin to determine its appropriate identity before using it in manufacturing your OTC topical drug products. The use of ingredients contaminated with DEG or EG has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol to help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for DEG or EG contamination at https://www.fda.gov/media/167974/download. Identity testin…
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 is the standard FDA response window for a warning letter?
- FDA warning letters typically require a written response within 15 working days of receipt, outlining the corrective and preventive actions the company will take.
- Has Woodbine Products Company Inc. had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for Woodbine Products Company Inc. as of 2026-08-04. Argus ingests new FDA enforcement records daily.
- What FDA violations was Woodbine Products Company Inc. cited for?
- The FDA Warning Letter to Woodbine Products Company Inc. (issuing office: Center for Drug Evaluation and Research (CDER)) cites: CGMP/Finished Pharmaceuticals/Adulterated. Classification: CGMP — Current Good Manufacturing Practice.
- When did FDA issue the warning letter to Woodbine Products Company Inc.?
- FDA issued the letter (MARCS-CMS 729345) on 2026-07-27 and posted it publicly on fda.gov on 2026-08-04.
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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). Warning Letter Record: Woodbine Products Company Inc. (2026-07-27) — CGMP/Finished Pharmaceuticals/Adulterated. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-woodbine-products-company-inc-2026-07-27-cgmp
"Warning Letter Record: Woodbine Products Company Inc. (2026-07-27) — CGMP/Finished Pharmaceuticals/Adulterated." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-woodbine-products-company-inc-2026-07-27-cgmp.
Argus HQ Research. "Warning Letter Record: Woodbine Products Company Inc. (2026-07-27) — CGMP/Finished Pharmaceuticals/Adulterated." Digital Empire Holdings LLC. Accessed August 5, 2026. https://argushq.ai/fda/warning-letter/fda-wl-woodbine-products-company-inc-2026-07-27-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_woodbine_products_company_inc_2026_07_27_cgmp_2026,
title = {Warning Letter Record: Woodbine Products Company Inc. (2026-07-27) — CGMP/Finished Pharmaceuticals/Adulterated},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-woodbine-products-company-inc-2026-07-27-cgmp},
note = {Accessed: August 5, 2026}
}