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

The FDA issued a Warning Letter to Age Management Institute Santa Barbara following an inspection from March 22 to April 12, 2021, which revealed serious deficiencies in producing sterile drug products for IV therapy. The firm voluntarily ceased production of these products as of the inspection date.

The inspection found that drug products intended to be sterile were prepared, packed, or held under insanitary conditions, rendering them adulterated under Section 501(a)(2)(A) of the FDCA. Specific violations included: 1. Lack of a certified ISO 5 classified area for sterile compounding. 2. Visibly dirty equipment and surfaces in aseptic processing areas, such as a dirty filter, staining, and peeling paint on a (b)(4) hood, a dirty air vent, and carpeted floor in the "IV storage and mixing room." 3. A refrigerator with dripping and standing water used to store sterile drug products, with containers/closures in direct contact with condensate. 4. Distribution of drug products prepared using expired components, a prohibited act under Section 301(k) of the FDCA.

The FDA acknowledged the firm's response to the Form FDA 483 and the cessation of production. The FDA strongly recommends a comprehensive assessment of operations by a third-party consultant if the firm decides to resume sterile drug product production. The firm must notify the FDA within fifteen working days of receipt of the letter regarding steps taken or