Age Management Institute Santa Barbara — FDA Warning Letter Findings

Your facility lacked a certified ISO 5 classified area for sterile compounding.

Your firm distributed drug products that were prepared using expired components. It is a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulterated. C. Corrective Actions We have reviewed your firm’s response to the Form FDA 483. We acknowledge that your firm voluntarily ceased production of drug…

Your aseptic processing areas had difficult to clean and visibly dirty equipment and surfaces. For example: a. A (b)(4) hood, used to produce drug products purporting to be sterile, had a visibly dirty filter installed. Also, there was staining and peeling paint on the (b)(4) hood surfaces and supporting table. b. An air vent in the “IV storage and mixing room” was visibly dirty and part of the floor was covered with carpet. c. A refrigerator with dripping and standing water on the inside shelf was used to store sterile drug products used to produce IV therapy products. The containers/closures were in direct contact with the condensate water.