# FDA 483 - Q LABS, LLC - April 25, 2025

Source: https://www.globalkeysolutions.net/records/483/q-labs-llc/a25ebc6b-7909-4103-a334-6ac58a49ef1e

> FDA 483 for Q LABS, LLC on April 25, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Q LABS, LLC
- Inspection Date: 2025-04-25
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: Q LABS, LLC, a contract testing laboratory in Cincinnati, was cited for significant deficiencies in its quality control unit. The inspection revealed inadequate investigations into out-of-specification results and non-conformances, as well as a failure to ensure proper second-person review of microbiology laboratory records. These issues indicate a lack of thoroughness in their quality system for drug product testing.

## Related Documents

- [483 - 2019-11-21](https://www.globalkeysolutions.net/records/483/q-labs-llc/67684f99-327b-463c-aec6-0aeb06518093)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/rafeeq-a-habeeb/ac58c0b7-bd42-4037-8ccb-bf0351b7744f)
- [Martin M. Kimani](https://www.globalkeysolutions.net/people/martin-m-kimani/fbc296cc-e80e-46f4-a34a-848c8b20da05)

Company: https://www.globalkeysolutions.net/companies/q-labs-llc/3923e3f2-bd54-4e3a-b482-901a7807f845

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22