# FDA 483 - AnazaoHealth Corporation - September 19, 2019

Source: https://www.keypedia.com/records/483/anazaohealth-corporation/f7b7a034-e8f6-4d80-a4d1-7377905f611d

> FDA 483 for AnazaoHealth Corporation on September 19, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AnazaoHealth Corporation
- Inspection Date: 2019-09-19
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: During an FDA inspection, deficiencies were noted in the aseptic processing areas and material flow at a sterile compounding outsourcing facility.

**Violations and Observations:**

1.  **Aseptic Processing Area Cleaning and Disinfection:**
    *   The firm lacks a visual inspection requirement to verify the completion and effectiveness of cleaning for classified laminar flow hoods/biosafety cabinets and cleanrooms.
    *   During a walk-through on September 9th, despite being informed rooms were in "clean status":
        *   Accumulated cleaning residue was found in LFH (b)(4) Cleanroom (b)(4).
        *   Small cracks/fractures were observed in the (b)(4) side paneling of LFHs (b)(4) and (b)(4).
        *   A small piece of plastic (1/2-inch x 1/8 inch) was stuck in the (b)(4) front grill of BSC (b)(4) Cleanroom (b)(4).
        *   A 2-inch string of Teflon tape was dangling from a (b)(4) inside BSC (b)(4) Cleanroom (b)(4).

2.  **Material Flow and Contamination Prevention:**
    *   The flow of components, drug product containers, closures, and in-process materials through the building is not designed to prevent contamination.
    *   Specifically, (b)(4) in

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## Related Officers

- [Supervisory microbiologist](https://www.keypedia.com/people/zachery-l-miller/e7ff2001-1e81-4483-9e9b-288b7e92c719)

Company: https://www.keypedia.com/companies/anazaohealth-corporation/4574c7ce-9831-453e-92f2-0dee1a2604e6

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