FDA WARNING_LETTER - MICROspecialties, Inc. - May 10, 2011

On June 28, 2011, the FDA issued a Warning Letter to MICROspecialties, Inc. following an inspection from April 25 to May 10, 2011. The inspection revealed that the firm's sterile, single-use, ophthalmic surgical blades are adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act, as their manufacturing, packing, storage, or installation methods do not conform to the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Failure to validate processes (21 CFR § 820.75(a)):** The firm failed to re-validate the gamma irradiation sterilization process after significant changes in 2008 (new manufacturing location, new blade packaging configuration). Additionally, equipment (package seal machine, thermal press) and manufacturing processes were not qualified or re-validated after the 2008 physical relocation. 2. **Failure to identify product acceptance status (21 CFR § 820.86):** Products sent to a contract sterilizer were not identified as "sterile" or "non-sterile" as per the contract agreement, indicating a lack of clear acceptance status. 3. **Failure to adequately document acceptance activities (21 CFR § 820