FDA WARNING_LETTER - Craig General Hospital - August 26, 2008

The FDA conducted an inspection of Craig General Hospital from July to August 2008, identifying serious Good Manufacturing Practice (GMP) violations under Section 501(a)(2)(B) of the federal Food, Drug, and Cosmetic Act and 21 CFR Parts 600-680. Key deficiencies included the failure to maintain comprehensive written Standard Operating Procedures (SOPs) for blood and blood component processing, compatibility testing, and storage (21 CFR 606.100(b)). This led to an employee's failure to follow procedures, resulting in an incompatible red blood cell transfusion and a patient's death. Inadequate or missing SOPs were also noted for platelets, Cryoprecipitate AHF, and Fresh Frozen Plasma (FFP) handling. The hospital failed to adequately identify and handle test samples, causing incorrect crossmatching (21 CFR 606.140(c)). Equipment calibration was deficient, with thermometers used for monitoring and compatibility testing not regularly calibrated against NIST-traceable standards (21 CFR 606.60(a)). Furthermore, the firm failed to maintain adequate processing, storage, distribution, and general records, lacking documentation for visual inspections, temperatures upon receipt, and calibration activities (21 CFR 606.160(b)). The FDA deemed the hospital's November 4, 2008, response to the FDA-483 inadequate for several items, requiring more specific and separate SOPs for critical processes and adherence to correct regulatory guidelines for product expiration. The hospital must provide a written response within fifteen working days detailing corrective actions and documentation, with potential administrative or regulatory actions, including seizure or injunction, if violations are not corrected.