Central Admixture Pharmacy Services, Inc.
FDA issued a warning letter to Central Admixture Pharmacy Services, Inc. (CAPS Allentown), a 503B outsourcing facility, following a February–March 2023 inspection that found serious CGMP deficiencies and insanitary conditions in sterile drug compounding operations. The agency cited failures to adequately investigate microbial contamination in ISO 5 aseptic processing areas and deficient laboratory controls, rendering drug products adulterated under FDCA sections 501(a)(2)(A) and 501(a)(2)(B). CAPS had already initiated a voluntary recall of all sterile drug products within expiry on April 28, 2023, due to lack of sterility assurance. FDA warned that failure to adequately address violations may result in seizure and injunction, and noted similar CGMP deficiencies at sister facilities CAPS Phoenix and CAPS San Diego.
Required actions (3)
on April 28, 2023, your firm initiated a voluntary recall of all drug products intended or expected to be sterile, within expiry, due to lack of sterility assurance.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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