# FDA 483 - Michael A. Werner MD PC/dba M.A.Z.E Laboratories - August 19, 2022

Source: https://www.globalkeysolutions.net/records/483/michael-a-werner-md-pcdba-maze-laboratories/b8a51388-2e0e-47a5-b0f1-778d23298d3a

> FDA 483 for Michael A. Werner MD PC/dba M.A.Z.E Laboratories on August 19, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Michael A. Werner MD PC/dba M.A.Z.E Laboratories
- Inspection Date: 2022-08-19
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Michael A. Werner MD PC/dba M.A.Z.E Laboratories in New York, NY, received a Form 483 with one observation concerning inadequate donor screening practices. The firm failed to properly screen directed semen donors for various communicable disease agents, including HTLV I/II, sepsis, and ZIKV, using outdated or insufficient medical history questionnaires. This resulted in the release of vials from inventory for donors whose eligibility was not fully determined according to regulations.

## Related Officers

- [Amy W. Yan-Mai](https://www.globalkeysolutions.net/people/amy-w-yan-mai/00551315-3a03-4327-ab3a-71de5c1577d4)

Company: https://www.globalkeysolutions.net/companies/michael-a-werner-md-pcdba-maze-laboratories/4ccb955a-447b-49a3-809d-a410b20e096d

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961