# FDA 483 - Midlab Incorporated - August 05, 2022

Source: https://www.globalkeysolutions.net/records/483/midlab-incorporated/87e4a28f-06e5-4746-86c5-0c7812b7e7a8

> FDA 483 for Midlab Incorporated on August 05, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Midlab Incorporated
- Inspection Date: 2022-08-05
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: Midlab Incorporated, an OTC drug manufacturer in Athens, TN, was inspected and received a Form 483 with six observations. The inspection revealed significant deficiencies in manufacturing process validation, microbial testing, stability programs, component identity testing, quality control unit responsibilities, and reprocessing procedures. These issues indicate a lack of adequate controls for ensuring consistent drug product quality and safety.

## Related Documents

- [WARNING_LETTER - 2022-08-05](https://www.globalkeysolutions.net/records/warning_letter/midlab-incorporated/692d5adb-89fe-47ab-b117-9203e518ebdc)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/clinton-j-lott/ac4c7d18-13fd-4b1b-b2a1-06794c9960c7)

Company: https://www.globalkeysolutions.net/companies/midlab-incorporated/695d3dd9-e783-4051-8a75-9db1d10dd1e9

Office: https://www.globalkeysolutions.net/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea