FDA WARNING_LETTER - Crown Health Care Laundry Services, Inc. - November 25, 2009

On November 17-25, 2009, an FDA inspection of Crown Health Care Laundry Services, Inc. in Selma, Alabama, revealed that their reusable sterile surgical drape packs are adulterated under Section 501(h) of the Federal Food, Drug, and Cosmetic Act. The manufacturing, packing, storage, or installation methods, facilities, or controls do not conform to the Quality System regulation (21 CFR Part 820).

Violations include: 1. Failure to establish and maintain quality audit procedures and conduct audits by independent individuals (21 CFR 820.22). 2. Failure of executive management to review the quality system at defined intervals (21 CFR 820.20(c)). 3. Failure to document all required corrective and preventive action (CAPA) activities and results, specifically for sterilization cycle deviations (21 CFR 820.100(b)). 4. Failure to validate processes, such as cleaning and drying, where results cannot be fully verified by subsequent inspection and test (21 CFR 820.75(a)). The firm's response was inadequate. 5. Failure to develop, conduct, control, and monitor production processes to ensure device conformity, specifically lacking procedures for cleaning and drying equipment and operations (21 CFR 820.70(a)). The firm's response