FDA WARNING_LETTER - Aegle Nutrition LLC - February 07, 2018

The FDA inspected Aegle Nutrition, LLC's Carrollton, Texas facility, manufacturing dietary supplements, from November 28 to December 1, 2017, with a follow-up from February 5-7, 2018. The inspection revealed significant violations of FDA's Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111) and Acidified Foods regulation (21 CFR Part 114), rendering products adulterated. Several products were also deemed misbranded under section 403 of the Act.

Key violations include: - **Adulterated Dietary Supplements:** Failure to establish specifications for identity, purity, strength, composition, and contamination limits for components (21 CFR 111.70(b)(2), 111.70(b)(3)). Failure to establish finished product specifications (21 CFR 111.70(e)). Quality control personnel approving and releasing products not meeting specifications (21 CFR 111.123(b)(2)). Master Manufacturing Records (MMRs) lacking necessary specifications and procedures (21 CFR 111.205(b)(1), 111.210). - **Adulterated Acidified Foods:** Failure to file scheduled processes with FDA for acidified products (21 CFR 108.25(c)(