# FDA 483 - Q LABS, LLC - November 21, 2019

Source: https://www.globalkeysolutions.net/records/483/q-labs-llc/67684f99-327b-463c-aec6-0aeb06518093

> FDA 483 for Q LABS, LLC on November 21, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Q LABS, LLC
- Inspection Date: 2019-11-21
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: Q Laboratories Inc, a control laboratory in Cincinnati, OH, was cited for failing to fully follow its quality control unit procedures. Specifically, the firm did not close out-of-specification (OOS) investigations within the required timeframe and lacked proper justification documentation for extensions, as mandated by its own SOPs. This indicates deficiencies in their quality system and adherence to internal protocols.

## Related Documents

- [483 - 2025-04-25](https://www.globalkeysolutions.net/records/483/q-labs-llc/a25ebc6b-7909-4103-a334-6ac58a49ef1e)

## Related Officers

- [Jon P. Antoniou](https://www.globalkeysolutions.net/people/jon-p-antoniou/e42f4f7d-dbdb-4d85-a755-92cb29c249bc)

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