# FDA 483 - Safetec Of America, Inc. - November 15, 2024

Source: https://www.keypedia.com/records/483/safetec-of-america-inc/3f8f86e3-c84b-45ee-bb20-2c5b539a3699

> FDA 483 for Safetec Of America, Inc. on November 15, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Safetec Of America, Inc.
- Inspection Date: 2024-11-15
- Product Type: drugs
- Office Name: New York District Office
- Summary: Safetec Of America, Inc. in Buffalo, NY, was inspected by the FDA, revealing significant issues with its quality control unit and laboratory controls. The firm failed to adhere to its own procedures for annual product reviews and purified water system monitoring. Additionally, the company did not test incoming Ethyl Alcohol for methanol limits, which is used in various OTC drug products.

## Related Documents

- [483 - 2020-03-06](https://www.keypedia.com/records/483/safetec-of-america-inc/695b5e0b-b404-44c3-a162-8747745d7e8e)

## Related Officers

- [Vivin George](https://www.keypedia.com/people/vivin-george/0b0ee298-a577-4bee-b18e-42da0c3bb148)
- [Raihan A. Chowdhury](https://www.keypedia.com/people/raihan-a-chowdhury/739813d5-2f9b-4048-91c7-911fd595f8d3)

Company: https://www.keypedia.com/companies/safetec-of-america-inc/1d747a2c-72ac-42e1-8de1-542150a7ffad

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d