Central Admixture Pharmacy Services, Inc. – FDA Warning Letter, Jul 31, 2023

The FDA issued a Warning Letter to CAPS Phoenix following a June-July 2023 inspection, identifying serious deficiencies in sterile drug production. The facility, registered as an outsourcing facility, produced adulterated drugs under insanitary conditions, including visibly dirty production areas and equipment, and inadequate corrective action after microbial contamination in the ISO 5 aseptic processing area.

Additional CGMP violations cited include: * Failure of the quality control unit to ensure CGMP compliance (21 CFR 211.22). * Failure to thoroughly investigate discrepancies or failures to meet specifications (21 CFR 211.192). * Lack of appropriate laboratory determination of conformance to final specifications prior to release (21 CFR 211.165(a)). * Failure to maintain equipment for aseptic conditions (21 CFR 211.42(c)(10)(vi)). * Failure to establish an adequate stability testing program (21 CFR 211.166(a)). * Failure to document accuracy, sensitivity, specificity, and reproducibility of test methods (21 CFR 211.165(e)). * Failure to control computer systems to ensure only authorized personnel institute changes (21 CFR 211.68(b)).

The FDA acknowledged the firm ceased production/distribution in August/July 2023 and initiated voluntary