FDA WARNING_LETTER - Ibitta Enterprises, Inc. - May 21, 2019

The FDA issued a Warning Letter to Ibitta Enterprises, Inc. following an inspection of their dietary supplement manufacturing facility from May 10-21, 2019. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111), rendering their dietary supplement products adulterated under 21 U.S.C. § 342(g)(1).

Key violations include: 1. Failure to establish specifications for identity, purity, strength, and composition of finished dietary supplement batches (21 CFR 111.70(e)). 2. Failure to establish specifications for each component used in manufacturing, including identity, purity, strength, and composition (21 CFR 111.70(b)(1) and (b)(2)). 3. Failure to establish specifications for dietary supplement labels (21 CFR 111.70(d)). 4. Failure to prepare and follow a written Master Manufacturing Record (MMR) with necessary control specifications (21 CFR 111.205(b)(1), 21 CFR 111.210), including procedures for sampling, manual operations verification, and corrective action plans. 5. Batch Production Records (BPRs) lacked complete information, such as equipment identity, maintenance dates, unique identifiers for packaging/labels, theoretical