Apollo Care, LLC
FDA issued a warning letter to Apollo Care, LLC, a 503B outsourcing facility in Columbia, MO, following a March 2025 inspection that revealed serious sterility assurance deficiencies in the production of sterile compounded drug products. The facility was found to have produced adulterated drugs under FDCA sections 501(a)(2)(A) and 501(a)(2)(B), including insanitary conditions, inadequate microbial contamination controls, and multiple CGMP violations. Apollo Care had already initiated a voluntary recall of a fentanyl/ropivacaine lot due to lack of sterility assurance, but FDA found several corrective action responses inadequate or insufficiently documented. FDA demands a written response within 15 working days and warns that failure to adequately address violations may result in seizure or injunction.
Required actions (2)
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.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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