FDA WARNING_LETTER - Central Admixture Pharmacy Services, Inc. - August 25, 2023

The FDA issued a Warning Letter to Central Admixture Pharmacy Services Inc. (CAPS) San Diego, following an inspection from July 10 to August 25, 2023. The facility, registered as an outsourcing facility under section 503B of the FDCA, was de-registered as of October 17, 2023. The inspection revealed that drug products failed to meet 503B conditions and exhibited serious deficiencies in sterile drug production, posing patient risks.

Violations included misbranding due to inadequate labeling (e.g., missing established drug names for Ephedrine Sulfate, Fentanyl Citrate) and failure to submit adverse event reports. These failures render the compounded drugs ineligible for exemptions from FDA approval, adequate directions for use, and Drug Supply Chain Security Act requirements.

The facility's drug products were deemed adulterated under FDCA sections 501(a)(2)(A) and 501(a)(2)(B) due to insanitary conditions and CGMP violations. Insanitary conditions included inadequate product evaluation after microbial contamination in ISO 5 areas, improper gowning practices, insufficient material disinfection during transfer, and flawed surface sampling. CGMP violations encompassed failures in quality control unit procedures (21 CFR 211.22(d)), investigation of discrepancies (21 CFR 211.192), prevention of microbiological contamination (21 CFR