Apex, NC Plant Receives FDA Warning Letter for cGMP Violations
November 14th, 2024 // 2:32 pm @ jmpickett
FDA delivered a warning letter to Choice All Natural, Inc., also known as Om Botanical, for major cGMP violations for finished pharmaceuticals. The letter was dated Oct. 24, 2024, and followed an FDA audit of Choice Natural’s manufacturing plant in Apex, North Carolina.
The FDA warning letter stated that Choice All Natural isn’t registered with FDA, as section 510 of the FD&C Act requires. Also, 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 unregistered with FDA as the Act requires.
During the inspection, the FDA investigator noticed several cGMP violations, such as not maintaining the buildings used in the manufacture and processing of drugs in a sanitary manner. The letter also noted that there were infestations of insects, birds, rodents, and other vermin in the manufacturing facility.
The company also failed to have for every batch of drugs, correct lab determination of satisfactory conformance to final specs for the drug. The company also did not include the identity and strength of every active ingredient before releasing them to the market. Last, Choice All Natural didn’t conduct necessary laboratory testing that are required to ensure that products are free of hazardous microorganisms.
