# FDA 483 - Safetec Of America, Inc. - March 06, 2020

Source: https://www.globalkeysolutions.net/records/483/safetec-of-america-inc/695b5e0b-b404-44c3-a162-8747745d7e8e

> FDA 483 for Safetec Of America, Inc. on March 06, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Safetec Of America, Inc.
- Inspection Date: 2020-03-06
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Safetec Of America, Inc. in Buffalo, NY was inspected from March 2-6, 2020, revealing significant deficiencies in quality control and equipment maintenance. The firm failed to follow written procedures for non-conformance reports and out-of-specification investigations, and lacked adequate controls over computer systems for master batch records. Additionally, a mixer in a clean room had missing and flaking paint, posing a contamination risk to drug products.

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## Related Officers

- [Johnna L. Bleem](https://www.globalkeysolutions.net/people/johnna-l-bleem/3fe669bf-e354-4cdc-9337-d5ceb23f1c9f)

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

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