# FDA WARNING_LETTER - MICROspecialties, Inc. - February 18, 2025

Source: https://www.keypedia.com/records/warning_letter/microspecialties-inc/eb8755c7-b7e1-4b8a-a91d-080c34278731

> FDA WARNING_LETTER for MICROspecialties, Inc. on February 18, 2025. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: MICROspecialties, Inc.
- Inspection Date: 2025-02-18
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

## Related Documents

- [483 - 2025-02-18](https://www.keypedia.com/records/483/microspecialties-inc/16e4596b-9379-4e60-967d-13480c70bdaa)

## Related Officers

- [Rick Brinsmade](https://www.keypedia.com/people/rick-brinsmade/a9cd00c3-fa04-4b26-a2b3-93164829b5cc)
- [Matthew G. Hillebrenner](https://www.keypedia.com/people/matthew-g-hillebrenner/e076699e-8da2-4223-a114-b33339bdf225)

Company: https://www.keypedia.com/companies/microspecialties-inc/66c1d396-f29e-4c9b-af68-601b9c9ddace

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7