Regulations

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

FDA’s inspection of Choice All Natural (doing business as Om Botanical) was conducted earlier this year.

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By: Christine Esposito

Editor-in-Chief

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, ...

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