FDA Cites Jubilant HollisterStier General Partnership in 2026-05-28 Warning Letter — CGMP/Finished Pharmaceuticals/Adulterated
Letter issued · posted to fda.gov .
Subject as published: CGMP/Finished Pharmaceuticals/Adulterated
TL;DR
FDA issued a Warning Letter to Jubilant HollisterStier General Partnership on 2026-05-28 citing: CGMP/Finished Pharmaceuticals/Adulterated. Full letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jubilant-hollisterstier-general-partnership-723537-05282026
Argus analysis
Jubilant HollisterStier General Partnership (MARCS-CMS 723537, FEI 3001623073) received an FDA Warning Letter dated May 28, 2026 from the Center for Drug Evaluation and Research (CDER). The letter cites: CGMP/Finished Pharmaceuticals/Adulterated. FDA posts Warning Letters to fda.gov after an internal review period; this one was made public on June 23, 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 Jubilant HollisterStier General Partnership MARCS-CMS 723537 — May 28, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Return Receipt Requested Reference #: 320-26-81 Product: Drugs Recipient: Recipient Name Mr. Christopher S. Preti Recipient Title President, Chief Executive Officer Jubilant HollisterStier General Partnership 16751 Trans-Canada Highway Kirkland QC H9H 4J4 Canada Issuing Office: Center for Drug Evaluation and Research (CDER) United States Warning Letter 320-26-81 May 28, 2026 Dear Mr. Preti: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Jubilant HollisterStier General Partnership, FEI 3001623073, at 16751 Trans-Canada Highway, Kirkland, from October 20 to November 3, 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). We reviewed your November 25, 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. 1. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)). A. Our inspection identified aseptic processing design deficiencies which pose significant hazards to drug product sterility, as well as multiple inadequacies in your smoke studies. For example: During a smoke study simulating an aseptic intervention of the (b)(4) line, an operator extended their upper body over the conveyor. This design flaw disrupted (b)(4) air and compromised protection of the critical ISO 5 zone. Smoke studies demonstrated air movement across the operator’s body and flowing toward exposed vials. You also performed a smoke study on the (b)(4) filling line to evaluate removal of vials from the (b)(4) at the (b)(4) . During this study an operator (b)(4) the large (b)(4) and placed their upper torso inside the ISO 5 classified area. The operator also used gloved hands instead of sterile tools to remove vials. In order to (b)(4) the (b)(4) , operators opened a small (b)(4) by reaching their entire forearm inside the ISO 5 classified area and manually turning a (b)(4) . These and other hazardous interventions occurred at critical locations in your aseptic processing area. Any compromise of (b)(4) protection expos…
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 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 Jubilant HollisterStier General Partnership had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for Jubilant HollisterStier General Partnership as of 2026-06-23. Argus ingests new FDA enforcement records daily.
- What FDA violations was Jubilant HollisterStier General Partnership cited for?
- The FDA Warning Letter to Jubilant HollisterStier General Partnership (issuing office: Center for Drug Evaluation and Research (CDER)) cites: CGMP/Finished Pharmaceuticals/Adulterated. Classification: CGMP — Current Good Manufacturing Practice.
argus.hq
Don’t find out about the next one six weeks late.
Argus reads every FDA Warning Letter the day it publishes, summarizes it against your watchlist, and lands the ones touching your business in your inbox at 6am ET. $199/month. Cancel any time.
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 Jubilant HollisterStier General Partnership in 2026-05-28 Warning Letter — CGMP/Finished Pharmaceuticals/Adulterated. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-jubilant-hollisterstier-general-partnership-2026-05-28-cgmp
"FDA Cites Jubilant HollisterStier General Partnership in 2026-05-28 Warning Letter — CGMP/Finished Pharmaceuticals/Adulterated." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-jubilant-hollisterstier-general-partnership-2026-05-28-cgmp.
Argus HQ Research. "FDA Cites Jubilant HollisterStier General Partnership in 2026-05-28 Warning Letter — CGMP/Finished Pharmaceuticals/Adulterated." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-jubilant-hollisterstier-general-partnership-2026-05-28-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_jubilant_hollisterstier_general_partnership_2026_05_28_cgmp_2026,
title = {FDA Cites Jubilant HollisterStier General Partnership in 2026-05-28 Warning Letter — CGMP/Finished Pharmaceuticals/Adulterated},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-jubilant-hollisterstier-general-partnership-2026-05-28-cgmp},
note = {Accessed: July 13, 2026}
}