# FDA 483 - AnazaoHealth Corporation - February 22, 2013

Source: https://www.keypedia.com/records/483/anazaohealth-corporation/3259da8a-12fc-4df1-95ad-c9a7ef6699fa

> FDA 483 for AnazaoHealth Corporation on February 22, 2013. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AnazaoHealth Corporation
- Inspection Date: 2013-02-22
- Product Type: Drugs
- Office Name: Florida District Office
- Summary: The FDA Form 483 details numerous deficiencies at a facility producing sterile drug products, specifically for Pain Management and Nuclear preparations.

**Key Violations and Observations:**

*   **Sterility Assurance & Validation:**
    *   Media fills for Pain Management products do not simulate actual production (e.g., non-sterile media preparation in uncontrolled areas, open media exposed to disinfectants, no growth promotion tests, no environmental monitoring during fills, sterilizing filter removal for medium-risk products, lack of worst-case conditions).
    *   High-volume media fills are similarly deficient, using incorrect vial sizes and lacking proper sterilization for production vials/stoppers.
    *   Sterilization parameters for autoclaves are not established, written, or readily available.
    *   Technicians used incorrect sterilization parameters for utensils.
    *   Sterile supplies (glassware, utensils) were observed with stains, tears, and lacked sterilization dates.
    *   Sterile bottles were refilled with non-sterile solutions in-house without obliterating original labels, leading to confusion.
    *   Components disinfected with spray were wiped with dirty rags.
    *   Supplies lacked unique load/batch numbers and sterilization dates, raising concerns about the use of supplies from failed or expired runs.
    *   Sterilization processes for products from non-sterile components are not validated, and pre-filtration bioburden limits are not established.
    *   Ster

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## Related Officers

- [Investigator](https://www.keypedia.com/people/lesley-satterwhite/030978c6-daaa-42e9-bf63-f90a5647f0f0)
- [Robert C. Steyert](https://www.keypedia.com/people/robert-c-steyert/8ebd3758-8970-411b-8281-5297de05ce48)
- [Ileana Barreto-Petit](https://www.keypedia.com/people/ileana-barreto-petit/e5c865ac-14a2-47d4-954b-464a865e8684)

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

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9