# FDA WARNING_LETTER - Analytical Food Laboratories Inc. - May 17, 2024

Source: https://www.keypedia.com/records/warning_letter/analytical-food-laboratories-inc/4f4baf96-372f-4da8-a503-8b5e2c5a3c6c

> FDA WARNING_LETTER for Analytical Food Laboratories Inc. on May 17, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Analytical Food Laboratories Inc.
- Inspection Date: 2024-05-17
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA inspected Analytical Food Laboratories, Inc. in Grand Prairie, Texas, from May 7-17, 2024, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering tested drug products adulterated.

Key violations include:
1.  **Failure to establish and follow required laboratory control mechanisms (21 CFR 211.160(a) and 211.160(b)):**
    *   **Lack of method validation:** Analytical methods for OTC drug products (e.g., (b)(4) oral solution, (b)(4) tablets) were not validated, and written procedures for assay methods were absent.
    *   **Inadequate system suitability:** HPLC analyses lacked appropriate system suitability determination per USP <621>.
    *   **Inadequate growth promotion testing:** Microbiological media growth promotion tests (e.g., batches 06-19-23-3, 06-19-23-5) used only one indicator microorganism instead of all required challenge microorganisms per USP <61>.
    *   The firm's May 31, 2024, response was inadequate, lacking sufficient detail on corrective actions, complete validation protocols, study results, and a retrospective risk assessment for affected drug samples.

2.  **Quality control unit failure (21 CFR 211.

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## Related Officers

- [Director](https://www.keypedia.com/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)

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

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c