Choice All Natural, Inc. dba Om Botanical – FDA Warning Letter, Feb 26, 2024

The FDA issued a Warning Letter to Choice All Natural, Inc. dba Om Botanicals, Inc. following an inspection from January 17 to February 26, 2024, at their Apex, NC facility. The letter identifies significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Specific CGMP violations include: 1. **Facility Maintenance (21 CFR 211.56(a)):** Observed pest activity in raw material storage, water leaks and missing ceiling tiles in manufacturing, and non-CGMP activities (meal preparation, dishwashing, soiled garment storage) in the QC laboratory. The company's response was deemed inadequate for lacking sufficient detail on pest control, commitment to discontinue non-CGMP activities, and a risk assessment. 2. **Finished Product Testing (21 CFR 211.165(a) and 211.165(b)):** Failure to test drug products for identity, strength of active ingredients, and objectionable microorganisms prior to release. The company's response was inadequate for not committing to identity and strength testing and lacking specific test details. FDA also noted a sample of "OM BOTANICAL Rash & Itch" was contaminated with *Candida parapsilosis*, and the company's investigation into contaminated batches