Dibar Nutricional S. de R.L. de C.V. – FDA Warning Letter, Apr 22, 2020

The FDA issued a Warning Letter to Dibar Nutricional S. de R.L. de C.V. on March 10, 2021, following a review of records requested on April 22, 2020. The facility, an OTC drug product manufacturer, was found to have significant Current Good Manufacturing Practice (CGMP) violations, rendering its drug products adulterated.

Key violations include: 1. **Failure to verify component identity (21 CFR 211.84(d)(1))**: The firm did not adequately test incoming components, relying on sensory evaluation and random sampling for identity testing. 2. **Failure to perform finished product testing (21 CFR 211.165(a))**: The firm distributed numerous OTC drug product lots to the U.S. without conducting required release testing for identity and strength of active ingredients. 3. **Inadequate stability testing program (21 CFR 211.166(a))**: The firm lacked a comprehensive stability program to support the claimed shelf life, with insufficient data and testing in non-marketed container-closure systems. 4. **Inadequate equipment qualification (21 CFR 211.63)**: The firm failed to provide installation and operational qualification documentation for manufacturing equipment and lacked recent calibration information for scales.

The FDA recommends engaging a qualified CGMP consultant to