# FDA 483 - Analytical Food Laboratories Inc. - June 20, 2025

Source: https://www.globalkeysolutions.net/records/483/analytical-food-laboratories-inc/f7e577c1-96ce-451b-a33c-2c1abff1ddd9

> FDA 483 for Analytical Food Laboratories Inc. on June 20, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Analytical Food Laboratories Inc.
- Inspection Date: 2025-06-20
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: Analytical Food Laboratories Inc. in Grand Prairie, TX, a contract testing laboratory, was cited for significant deficiencies in its Quality Unit's oversight of cGMP drug product testing operations. The inspection revealed repeat observations regarding the failure to verify CAPA effectiveness, inadequate laboratory controls, and issues with consultant qualification, cleaning validation, and equipment calibration. These findings indicate a systemic lack of adherence to regulatory requirements for drug product testing.

## Related Documents

- [483 - 2024-05-17](https://www.globalkeysolutions.net/records/483/analytical-food-laboratories-inc/fe7b6b6e-5edd-4b8f-9ef6-3062aa96b231)
- [WARNING_LETTER - 2024-05-17](https://www.globalkeysolutions.net/records/warning_letter/analytical-food-laboratories-inc/4f4baf96-372f-4da8-a503-8b5e2c5a3c6c)

## Related Officers

- [Stephen P Tillis](https://www.globalkeysolutions.net/people/stephen-p-tillis/9591b28c-5e26-49cf-8cc7-0c2680b45e33)
- [issuing_officer](https://www.globalkeysolutions.net/people/inga-m-warr/f27805b8-c2ba-4af5-bf5e-ff2e2f511ec1)
- [Stephon D. Tillis](https://www.globalkeysolutions.net/people/stephon-d-tillis/32a4b5de-0dcc-4233-b7c8-b25cf691a138)
- [Milton J. De Jesus Tavarez](https://www.globalkeysolutions.net/people/milton-j-de-jesus-tavarez/24d4ed81-7c7e-42d2-8888-1c56c25eec67)

Company: https://www.globalkeysolutions.net/companies/analytical-food-laboratories-inc/05f0b77b-4efa-4d07-b01e-a8084d84b2e2

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9