# FDA 483 - Microbiological Consultants, Inc. - July 11, 2024

Source: https://www.globalkeysolutions.net/records/483/microbiological-consultants-inc/70f2018c-6b19-4a06-a11a-9f7b9e5bcf83

> FDA 483 for Microbiological Consultants, Inc. on July 11, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Microbiological Consultants, Inc.
- Inspection Date: 2024-07-11
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Microbiological Consultants Inc., a contract laboratory in Huntington, WV, revealed significant deficiencies. Observations included an inadequate number of qualified personnel, specifically only one analytical chemist for all chemical testing, and a lack of documented training for management overseeing microbiological lab records. Additionally, the firm failed to implement appropriate computer system controls, lacking unique user IDs and passwords for analytical instruments, leading to a lack of accountability for changes.

## Related Officers

- [Norman K. Starks](https://www.globalkeysolutions.net/people/norman-k-starks/4b8776e0-f96e-429c-94d1-40c0369f5378)

Company: https://www.globalkeysolutions.net/companies/microbiological-consultants-inc/9880c70b-61e8-4a6c-9e4b-a80c64fefa70

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