Warning Letter for cGMP Violations Sent To Apex, NC-based Company

The US Food and Drug Administration (FDA) sent a warning letter to Choice All Natural, Inc. (dba Om Botanical) regarding significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.

The letter, dated Oct. 21, 2024, followed an inspection of Choice Natural’s manufacturing facility in Apex, NC conducted between January 17 and February 26, 2024. FDA said the company’s methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP.

FDA also said that Choice All Natural, Inc., dba OM Botanical, is not duly registered with FDA as required by section 510 of the FD&C Act and 21 CFR Part 207. In addition, Om Botanical Rash & Itch, Om Botanical Acne Treatment, Om Botanical Eczema & Psoriasis Relief, Om Botanical Pain Relief, and Om Botanical Reef Safe Sunscreen SPF 30 are not listed with FDA as required by section 510(j) of the FD&C Act.  

During the inspection, FDA said its investigator observed specific violations including: failure to maintain the buildings used in the manufacture, processing, packing, or holding in a clean and sanitary condition and to keep them free of infestation by rodents, birds, insects, and other vermin; failure to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release; and failure to conduct appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms.