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

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)(