FDA WARNING_LETTER - Custom Nutraceuticals, LLC - January 23, 2020

The FDA inspected Custom Nutraceuticals, LLC's dietary supplement facility in Commack, NY, from January 8-23, 2020, and found significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111). This renders their Thermal Revolution Black, Anabolic Blackout Raspberry Lemonade, Militia Re-COMP, and Rhino Rampage Wildberry products adulterated. The firm did not respond to the Form FDA 483 issued on January 23, 2020.

Key violations include: 1. Failure to verify finished dietary supplement batches meet product specifications for identity, purity, strength, and composition (21 CFR 111.75(c)). Assay testing for several products was based on production input, not analytical testing of the finished product. 2. Failure to establish and follow laboratory control processes for selecting standard reference materials (21 CFR 111.315(d)). Raw material identification tests lacked comparison to a reference standard. 3. Quality control personnel approved and released a batch of Militia Re-COMP that did not meet established product specifications, as the raw material test results indicated a different ingredient than documented in the batch production record (21 CFR 111.123(b)(2)). 4. Failure to suitably dispose of obsolete or incorrect labels and packaging (21 CFR 111