Crothall Healthcare, Inc. – FDA Warning Letter, Jul 30, 2009

The FDA issued a Warning Letter to Crothall Healthcare, Inc. (Steripac) following a July 27-30, 2009 inspection of their Birmingham, Alabama facility, which manufactures sterile surgical linen packs. These products are classified as adulterated devices under Section 501(h) of the Act because their manufacture, packing, storage, or installation methods, facilities, or controls do not conform to the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

The letter details eight violations, citing inadequate responses to the FDA 483 observations. Key deficiencies include: 1. Failure to establish and maintain procedures for corrective and preventive action (CAPA), specifically lacking steps for verification/validation of effectiveness and an approval signature (21 CFR 820.100(a)). 2. Failure to establish and maintain procedures for controlling nonconforming product, with the submitted manual lacking requirements for evaluation, investigation, and notification (21 CFR 820.90(a)). 3. Inadequate complaint handling procedures, specifically failing to require evaluation for Medical Device Reporting (MDR) reportability and documentation of such evaluation (21 CFR 820.198(a)(3)). 4. Failure to document acceptance activities like inspections and tests, with no evidence of documentation or validation of