# FDA 483 - Microbac Laboratories, Inc. - May 24, 2021

Source: https://www.globalkeysolutions.net/records/483/microbac-laboratories-inc/b3087808-061d-41ce-95b0-93ba2e32ff65

> FDA 483 for Microbac Laboratories, Inc. on May 24, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Microbac Laboratories, Inc.
- Inspection Date: 2021-05-24
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Microbac Laboratories, Inc. in Sterling, VA, a contract testing laboratory, revealed significant deficiencies in their quality control unit. The firm failed to adequately document responsibilities and procedures, secure master files, and ensure proper quality review and signatures for out-of-specification reports and calibration documents. These issues indicate a lack of robust quality system controls.

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## Related Officers

- [Jaison J Eapen](https://www.globalkeysolutions.net/people/jaison-j-eapen/35b16029-11a0-452c-9413-a92dc120c529)

Company: https://www.globalkeysolutions.net/companies/microbac-laboratories-inc/e634e459-2807-4380-8097-9d66cb9d2d29

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e