# FDA 483 - AnazaoHealth Corporation - March 24, 2017

Source: https://www.keypedia.com/records/483/anazaohealth-corporation/5498a0dc-8043-4953-be1d-942e286e10d4

> FDA 483 for AnazaoHealth Corporation on March 24, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AnazaoHealth Corporation
- Inspection Date: 2017-03-24
- Product Type: Drugs
- Office Name: San Francisco District Office
- Summary: This FDA Form 483 details multiple observations from an inspection of an outsourcing facility.

**Facility and Operations:** The facility compounds drug products, including sterile injectables (e.g., Testosterone Cypionate, MIC with Cyanocobalamin, Methylcobalamin) and sterile pellets (e.g., Testosterone, Testosterone/Anastrozole, Estradiol).

**Violations and Observations:**

1.  **Inadequate Sterilization Process Validation:**
    *   Failure to maintain established sterilizing and depyrogenation parameters during November 2016 re-qualification of (b)(4) for 5mL glass vials and (b)(4) drug solution.
    *   Lack of scientific justification for using (b)(4) Sterilization Validation method for compounded drug products, specifically for pharmaceutical pellets, and its specificity for these products.
    *   Sterile pellet drug product batches produced for (b)(4) are not representative of routine manufacturing batches (e.g., (b)(4) vs. (b)(4) routine batches).
    *   Media fill batch (b)(4) was observed in an unmonitored hallway, lacking temperature data to confirm appropriate incubation.

2.  **Failure to Reject Non-Conforming Products:**
    *   Visual inspection failures: On 3/16/2017, Pharmacy Technician (b)(6) performed visual inspection for 1

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## Related Officers

- [Compliance Officer](https://www.keypedia.com/people/rumany-c-penn/021eb1e0-8de0-403f-9596-3e76624b2e5a)
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Company: https://www.keypedia.com/companies/anazaohealth-corporation/4574c7ce-9831-453e-92f2-0dee1a2604e6

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df