# FDA 483 - M.A.Z.E. Laboratories - December 17, 2021

Source: https://www.globalkeysolutions.net/records/483/maze-laboratories/6adf7f5b-ac3f-4957-8352-2c1dedefb0cc

> FDA 483 for M.A.Z.E. Laboratories on December 17, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: M.A.Z.E. Laboratories
- Inspection Date: 2021-12-17
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: M.A.Z.E. Laboratories in Purchase, NY, was cited for deficiencies in its human reproductive tissue operations, specifically concerning donor screening and record-keeping. The inspection revealed incomplete screening for Zika virus in semen donors and a failure to include required statements about CLIA certification for communicable disease testing in HCT/P records. These issues indicate a lack of adequate controls to ensure donor eligibility and product safety.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/anthony-n-onianwa/910dd164-8542-4259-b11f-ea3a3f6d7baa)

Company: https://www.globalkeysolutions.net/companies/maze-laboratories/a06f9370-2200-469a-9065-da24b30850de

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