FDA WARNING_LETTER - Medical Action Industries - October 09, 2007

On September 25 through October 9, 2007, an FDA inspection of Medical Action Industries, Inc. in Arden, North Carolina, revealed that the firm's medical procedure trays and kits were adulterated under 21 U.S.C. 351(h) because manufacturing methods, facilities, or controls did not conform to Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Violations included: 1. **Failure to fully validate and document processes (21 CFR 820.75(a)):** * No software validation/verification for the [redacted] planning system. * Bioburden determination was not performed in the 2005 ethylene oxide (EO) validation study, and routine testing commitment was lacking. * No product functionality and/or packaging integrity testing on post-sterilized products, despite customer complaints. 2. **Failure to investigate complaints (21 CFR 820.198(c)):** Inadequate investigation of rusty instruments and discolored medicine cups in Laceration Kits, including failure to identify root cause or contact affected customers. 3. **Failure to establish corrective and preventive action (CAPA) activities (21 CFR 820.100):** No formal CAPA system; failed to