Central Admixture Pharmacy Services, Inc.
Central Admixture Pharmacy Services, Inc. (CAPS), a 503B outsourcing facility in San Diego, CA, received an FDA Warning Letter following a July–August 2023 inspection that uncovered serious sterility assurance failures, CGMP violations, and failure to meet 503B conditions. The facility produced adulterated and misbranded sterile drug products (including Ephedrine Sulfate, Fentanyl Citrate, Ketamine Hydrochloride, and others) without adequate aseptic controls, proper labeling, or adverse event reporting. CAPS initiated voluntary recalls and subsequently permanently ceased operations at the San Diego location. FDA warned that failure to adequately address violations may result in seizure and injunction.
Flagged claims (4)
their labeling fails to bear adequate directions for their intended uses causing them to be misbranded under section 502(f)(1) of the FDCA.
Your facility did not submit adverse event reports to FDA in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations (or any successor regulations).
You do not have any FDA-approved applications on file for drug products that you compound.
Some of your facility's drug products, including Ephedrine Sulfate, Fentanyl Citrate, Hydromorphone Hydrochloride, Ketamine Hydrochloride, Succinylcholine Chloride, Vecuronium Bromide, and Lidocaine Hydrochloride did not include the following on the label: the established name of the drug product.
Required actions (4)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address any violations, or you may inform us that you do not intend to resume production of drugs intended or expected to be sterile or move any of your operations to a new location.
With respect to your labeling violations, FDA expects to evaluate compliance with section 503B(a)(10) of the FDCA upon reviewing any updated labels of compounded drug products that you submit in response to this letter.
FDA strongly recommends that if you decide to resume production of sterile drugs your management first undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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