# FDA WARNING_LETTER - Adept Life Science, LLC - April 27, 2022

Source: https://www.keypedia.com/records/warning_letter/adept-life-science-llc/243e4a9e-a574-4fdc-bd9c-a8b05249f498

> FDA WARNING_LETTER for Adept Life Science, LLC on April 27, 2022. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Adept Life Science, LLC
- Inspection Date: 2022-04-27
- Product Type: Food
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: The FDA inspected 2215 E Germann Rd, Chandler, Arizona, from April 11-27, 2022, identifying serious violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111), rendering products adulterated. The (b)(4) brand (b)(4) and (b)(4) brand (b)(4) products are also misbranded.

Key CGMP violations include:
1.  Failure to establish identity specifications for components like (b)(4) and (b)(4) blend (21 CFR 111.70(b)(1)).
2.  Failure to establish component specifications for purity and composition, such as for (b)(4) Premix (21 CFR 111.70(b)(2)).
3.  Failure to establish and follow laboratory control processes for selecting standard reference materials; third-party FTIR analysis used previous shipments as references, not ensuring thorough characterization (21 CFR 111.315(d)).
4.  Quality control operations failed to approve and release finished batches for distribution, specifically (b)(4) brand (b)(4), Lot # (b)(4) (21 CFR 111.123(a)(8)).
5.  Quality control personnel released a batch ((b)(4) brand (b)(

## Related Officers

- [E.](https://www.keypedia.com/people/mark-harris/b51ccb1e-3e75-427e-92da-78eb6f218366)

Company: https://www.keypedia.com/companies/adept-life-science-llc/0b7e32af-9c28-4671-92e2-80565e014b6a

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6