FDA 483 - Age Management Institute Santa Barbara - April 12, 2021

The FDA Form 483 documents observations from an inspection of a facility producing purportedly sterile drug products for intravenous (IV) infusion and IV syringes based on doctor's prescriptions.

Key observations include: 1. **Lack of HEPA Filtration:** No HEPA filter was present over the area where sterile product was exposed, specifically in the (b) (4) (b) (4) hood or the IV storage and mixing room. A (b) (4) was used instead of a HEPA filter in the hood, resulting in sterile drug products being produced in an unclassified area. Between 1/13/2021 and 2/25/2021, (b) (4) purportedly sterile drug products were produced under these conditions. 2. **Non-Microbial Contamination:** The production area, particularly the IV storage and mixing room, exhibited significant non-microbial contamination. This included: * Use of an expired (b) (4) (dated 08/28/2008) in the (b) (4) hood, with a dirty back. * A (b) (4) refrigerator storing sterile vials had water drips on caps, water in trays, and ice/frost buildup. * The (b) (4) hood's working surface had unknown stains and peeling paint on non-working surfaces.