FDA WARNING_LETTER - MICROspecialties, Inc. - February 18, 2025
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On May 8, 2025, the FDA issued a Warning Letter to Gaston S. Levesque, a contract manufacturer of Class I and II ophthalmic surgical devices in Middletown, CT, following an inspection from January 14, 2025, to February 18, 2025. The inspection revealed that the devices, including sterile I-PACK injection kits, punctum plugs, and microkeratome blades, are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation, 21 CFR Part 820.
Key violations include: 1. **Failure to establish and maintain procedures for finished device acceptance (21 CFR 820.80(d)):** The firm failed to implement its "Sterilization Process Control" procedure (QA-0041) for releasing sterile products. Specifically, four lots of I-PACK injection kits (Lot #: P62764979R, P63044983R, P62764965R, P62764970R) were released as sterile using fabricated Certificates of Processing (COPs) without actual sterilization, leading to Class II and Class I recalls. The firm's corrective actions, including personnel changes, procedural updates, and retrospective
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