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

Source: https://www.keypedia.com/records/483/age-management-institute-santa-barbara/3cd0dac2-f70d-4e64-ac25-c70638bb3560

> FDA 483 for Age Management Institute Santa Barbara on April 12, 2021. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Age Management Institute Santa Barbara
- Inspection Date: 2021-04-12
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: 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.

## Related Documents

- [483 - 2021-04-12](https://www.keypedia.com/records/483/age-management-institute-santa-barbara/3f57e805-4fb3-40c2-9b96-a50d6219da76)

## Related Officers

- [Consumer Safety Officer, Drug Specialist](https://www.keypedia.com/people/taichun-qin/62349336-96d6-4452-9c20-9084204b86bf)

Company: https://www.keypedia.com/companies/age-management-institute-santa-barbara/c8d93d94-d7f2-4b8f-ae44-c6c72bbfc3f8

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b