Age Management Institute Santa Barbara
FDA issued a warning letter to Age Management Institute Santa Barbara (owner Michael R. Repik, D.O.) following a March–April 2021 inspection that found serious sterile compounding deficiencies, including lack of a certified ISO 5 area, visibly dirty equipment and surfaces, and use of expired components in IV therapy drug products. These conditions rendered the compounded drug products adulterated under section 501(a)(2)(A) of the FDCA. The facility had voluntarily ceased IV therapy drug production at the time of inspection. FDA warned that failure to adequately address violations may result in seizure and injunction, and required a written response within 15 working days.
Required actions (3)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing if you have taken any specific steps 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.
The FDA strongly recommends that if you decide to resume production of sterile drug products, your management first undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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