After an inspection at the Pithampur plant, the USFDA issued a warning letter stating that the company s methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to good manufacturing practices, and that its drug products are adulterated.
The FDA issued a warning letter about nicotine gummies the first ever notification sent for such a product. The agency’s concern is that the flavored gummies resemble candy and pose a toxicity risk to children.