FDA Cites Eurofins SF Analytical Laboratories, Inc. in 2026-10-06 Warning Letter — CGMP/Finished Pharmaceuticals/Adulterated
Letter issued · posted to fda.gov .
Subject as published: CGMP/Finished Pharmaceuticals/Adulterated
TL;DR
At a glance: FDA's Center for Drug Evaluation and Research (CDER) issued a warning letter on October 6, 2026, to Eurofins SF Analytical Laboratories, Inc. (FEI 3014704316, Horsham, Pennsylvania) following an inspection June 1–3, 2026, citing significant CGMP violations for finished pharmaceutical testing. The letter documents systematic failures in microbiological data recording, including omission of "too numerous to count" results, failure to reject compromised media plates, lack of secondary verification for zero-count results, and selective reporting practices dating to February 2025—rendering drug product certificates of analysis potentially incomplete and unreliable.
Argus analysis
# FDA Warning Letter Analysis: Eurofins SF Analytical Laboratories, Inc.
**Company and Findings**
Eurofins SF Analytical Laboratories, Inc., a contract testing laboratory with locations in Horsham, Pennsylvania and New Berlin, Wisconsin, received a warning letter from the FDA's Center for Drug Evaluation and Research (CDER) on October 6, 2026, following an inspection conducted June 1–3, 2026. The FDA found significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. Specifically, the agency identified systematic failures in microbiological testing data integrity, including selective omission of test results and inadequate documentation practices that rendered drug product certificates of analysis potentially unreliable.
**Regulatory Citations**
The violations cited three primary sections of 21 CFR: 211.194(a) requires complete laboratory records derived from all necessary tests; 211.192 mandates thorough investigation of unexplained discrepancies or specification failures; and 211.22 holds quality units responsible for ensuring CGMP compliance. These regulations establish foundational expectations for data integrity, deviation management, and quality oversight in pharmaceutical testing. The violations reflected here—missing "too numerous to count" microbial results, zero colony-forming unit records lacking secondary verification, and use of visibly compromised culture media—constitute systematic documentation and quality control failures rather than isolated incidents.
**Next Steps and Industry Watch**
Eurofins has 15 business days from October 6, 2026, to respond with a comprehensive independent assessment, detailed CAPA plans addressing documentation systems and investigative procedures, and evidence of implementation. Compliance officers in analytical laboratory services should monitor whether Eurofins publishes corrective actions or whether the FDA takes enforcement action if remediation proves inadequate. Similar laboratories should review their own plate-reading verification procedures, media handling protocols, and secondary review mechanisms for zero or out-of-specification results.
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 Eurofins SF Analytical Laboratories, Inc. MARCS-CMS 736056 — October 06, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Reference #: 320-27-05 Product: Drugs Recipient: Recipient Name Mr. David Riggs Recipient Title President - EFSA Cluster Eurofins SF Analytical Laboratories, Inc. 2345 South 170th Street New Berlin , WI 53151 United States (b)(4) Issuing Office: Center for Drug Evaluation and Research (CDER) United States October 6, 2026 WARNING LETTER Reference number: 320-27-05 To Mr. David Riggs: This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) inspection of your facility. Promptly address the violations described herein without delay including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that exist at your facility. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. FDA Inspection Violations were observed and documented during an inspection of your contract testing laboratory, Eurofins SF Analytical Laboratories, Inc., FDA Establishment Identifier (FEI) 3014704316, at 215 Witmer Road, Horsham, Pennsylvania, from June 1 to 3, 2026. This inspection was conducted under FDA’s statutory authority and public health responsibilities to protect the public from unsafe, ineffective, and poor quality drugs. 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, the drug products you tested 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 June 22, 2026, response to our Form FDA 483 in detail. Violations of the Federal Food, Drug, and Cosmetic Act The following are violations identified during our inspection and review. As a reminder, this is not an all-inclusive list of violations at your facility. 1. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)). Your firm conducts microbiological analyses of components and drug products for your customers. You perform (b)(4) pour plate methods for microbial enumeration of (b)(4) samples. During the inspection, our investigator observed that your microbiologist fai…
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 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.
- What is the regulatory background for a CGMP — Current Good Manufacturing Practice warning letter?
- 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 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 Eurofins SF Analytical Laboratories, Inc. had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for Eurofins SF Analytical Laboratories, Inc. as of 2026-10-13. Argus ingests new FDA enforcement records daily.
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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 Eurofins SF Analytical Laboratories, Inc. in 2026-10-06 Warning Letter — CGMP/Finished Pharmaceuticals/Adulterated. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-eurofins-sf-analytical-laboratories-inc-2026-10-06-cgmp
"FDA Cites Eurofins SF Analytical Laboratories, Inc. in 2026-10-06 Warning Letter — CGMP/Finished Pharmaceuticals/Adulterated." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-eurofins-sf-analytical-laboratories-inc-2026-10-06-cgmp.
Argus HQ Research. "FDA Cites Eurofins SF Analytical Laboratories, Inc. in 2026-10-06 Warning Letter — CGMP/Finished Pharmaceuticals/Adulterated." Digital Empire Holdings LLC. Accessed October 14, 2026. https://argushq.ai/fda/warning-letter/fda-wl-eurofins-sf-analytical-laboratories-inc-2026-10-06-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_eurofins_sf_analytical_laboratories_inc_2026_10_06_cgmp_2026,
title = {FDA Cites Eurofins SF Analytical Laboratories, Inc. in 2026-10-06 Warning Letter — CGMP/Finished Pharmaceuticals/Adulterated},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-eurofins-sf-analytical-laboratories-inc-2026-10-06-cgmp},
note = {Accessed: October 14, 2026}
}