June 22, 2026 FDA Warning Letter: Genzyme Ireland Limited Cited for CGMP/Deviations/Biologics License Application (BLA)

FDA Warning Letter — Violations FDA cited at Genzyme Ireland Limited

WARNING LETTER Genzyme Ireland Limited MARCS-CMS 728681 — June 22, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via UPS and EMAIL Reference #: CBER 26-728681 Product: Biologics Recipient: Recipient Name Mr. Cian O'Brien Recipient Title Site Head Genzyme Ireland Limited Unit 701 IDA Industrial Park Old Kilmeaden Road Co. Waterford X91 TP27 Ireland Cian.OBrien@sanofi.com Issuing Office: Center for Biologics Evaluation and Research (CBER) United States WARNING LETTER June 22, 2026 CBER 26-728681 Dear Mr. O'Brien: The United States Food and Drug Administration (FDA) inspected your facility, located at the above address, between January 12, 2026, and January 20, 2026. During the inspection, FDA documented evidence of significant violations of current good manufacturing practice (CGMP) requirements, see 21 U.S.C. § 351(a)(2)(B) and 21 CFR parts 210 and 211, in the manufacture of your licensed biological products, Thymoglobulin (Anti-thymocyte Globulin [Rabbit]) and Altuviiio (antihemophilic factor [recombinant]) (collectively, “your products”). Because your methods, facilities, or controls for manufacturing, processing, packing, or holding drugs do not conform to CGMP, your 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 introduction of your products into interstate commerce is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. § 331(a). FDA’s inspection of your facility documented evidence of significant CGMP violations. At the conclusion of the inspection, FDA investigators issued a Form FDA-483, List of Inspectional Observations (Form FDA-483). The CGMP violations applicable to your products include, but are not limited to, the following: 1. Your firm’s quality control unit failed to exercise its responsibility to ensure that drug products are manufactured in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity, as required by 21 CFR 211.22. Specifically, your quality unit failed to exercise its responsibility to ensure compliance with the following CGMP requirements: a. Failure to ensure that laboratory records include complete data derived from all tests necessary to assure compliance with established specifications and standards, as required by 21 CFR 211.194(a). For example: i. Multiple non-viable particulate excursions and repeated (b)(4) test failures across multiple batches present in instrument histories were not documented in laboratory records for review and investigation. (b)(4) testing was repeated up to 11 times without documentation. ii. On multiple occasions, the number of active air monitoring samples documented in environmental monitoring records was not directly traceable to the instrument histories of the specific air samplers identified on those records. Additionally, logbooks documenting when environmental monitoring was performed were not always consistent with cleanroom entry and exit times for personnel performing the sampling. Consequently, these records could not be relied upon to accurately document environmental monitoring activities, as accurate records are critical to providing reliable evidence of environmental control. iii. Your laboratory records were incomplete because quality control personnel used uncontrolled Review Checklists to unofficially document laboratory record reviews, which were subsequently discarded. Additionally, updates to your records were not always traceable or attributable to a specific person. b. Failure to thoroughly investigate any unexplained discrepancy, or the failure of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed, as required by 21 CFR 211.192. For example, at the time of the inspection, your firm cancelled numerous deviations without investigating the root cause or assessing p