# FDA WARNING_LETTER - AnazaoHealth Corporation - January 30, 2015

Source: https://www.keypedia.com/records/warning_letter/anazaohealth-corporation/ca992af7-6044-4c59-ad88-9ce9217c1936

> FDA WARNING_LETTER for AnazaoHealth Corporation on January 30, 2015. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: AnazaoHealth Corporation
- Inspection Date: 2015-01-30
- Product Type: Drugs
- Office Name: San Francisco District Office
- Summary: This FDA Warning Letter, dated December 9, 2015, addresses AnazaoHealth Corporation, an outsourcing facility registered under section 503B of the FDCA. An inspection from January 20-30, 2015, revealed serious deficiencies in sterile drug product manufacturing, posing patient risks.

Key violations include:
- **Insanitary Conditions:** Failure to use sterile wipes or disinfectants in ISO 7 and ISO 5 areas, leading to adulterated products (501(a)(2)(A) FDCA).
- **CGMP Violations:** Adulterated drug products due to significant CGMP failures (501(a)(2)(B) FDCA), including:
    - Lack of written procedures for preventing microbiological contamination and validating aseptic processes (21 CFR 211.113(b)).
    - Failure to establish a cleaning/disinfecting system for aseptic conditions (211.42(c)(10)(v)).
    - Inadequate laboratory controls for specifications, sampling, and testing (21 CFR 211.160(b)).
    - Failure to investigate unexplained discrepancies or batch failures (21 CFR 211.192).
- **503B Non-Compliance:** Failure to meet conditions for exemptions, resulting in unapproved new drugs and misbranded drugs:
    -

## Related Documents

- [483 - 2015-01-30](https://www.keypedia.com/records/483/anazaohealth-corporation/a750c9b7-b6f7-4ed4-91ff-0eb58898411b)
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- [WARNING_LETTER - 2019-09-19](https://www.keypedia.com/records/warning_letter/anazaohealth-corporation/96a80429-398b-4c62-937d-781453c6af0f)

## Related Officers

- [Executive Secretary](https://www.keypedia.com/people/larry-l-pinson/8d90d168-d23c-423b-bca7-b2647eae99b1)
- [Director of Compliance Branch](https://www.keypedia.com/people/lawton-w-lum/96102f66-f6ae-4db9-9ba2-3bc619ae32e2)
- [Kathleen M. Lewis](https://www.keypedia.com/people/kathleen-m-lewis/c7f66b1a-d346-48cc-ab84-9ea6c2805268)
- [Russell A. Campbell](https://www.keypedia.com/people/russell-a-campbell/ed4e50b8-b6ee-4dcc-9e16-8e2757abd6f4)

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