Central Admixture Pharmacy Services, Inc.
FDA issued a warning letter to Central Admixture Pharmacy Services, Inc. (CAPS Phoenix), a 503B outsourcing facility in Phoenix, AZ, following a June–July 2023 inspection that found serious CGMP deficiencies and insanitary conditions in sterile drug production. Investigators observed visibly dirty production areas, inadequate microbial contamination responses, failures in quality control, batch release testing, stability programs, and unauthorized electronic record access. The facility had already voluntarily recalled products and ceased production, but FDA found corrective action responses inadequate and lacking supporting documentation. FDA warned that failure to address violations may result in seizure or injunction, and required a written response within 15 working days.
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.
If you intend to resume production of drugs in the future, please include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation.
you should notify this office fifteen (15) working days prior to resuming production of any drugs in the future.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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