FDA WARNING_LETTER - Creative Science, Inc. - March 13, 2017

The FDA conducted an animal drug manufacturing inspection of Creative Science, Inc. from March 6-13, 2017. While initial cGMP violations were addressed, a subsequent review of the firm's website and marketing materials revealed new concerns regarding the product P-Bloc.

The FDA determined that P-Bloc, marketed as a sterile injectable for temporary relief of neurological pain in animals, is an unapproved new animal drug. Evidence includes website claims of providing products to veterinary hospitals for various animal species, sales records showing shipments to animal facilities, and the product label indicating animal use. This violates sections 201(g)(1)(B), 201(v), 512(a), and 501(a)(5) of the FD&C Act, rendering the product unsafe and adulterated.

Furthermore, P-Bloc (NDC 53413-752) was inaccurately listed with the FDA as a "Human Prescription Drug," despite being for animal use. This misrepresentation led to the removal of P-Bloc's listing data from the FDA's online NDC Directory, citing the need for an accurate database to protect public health.

Creative Science, Inc. is required to notify the FDA within fifteen working days of receipt of the letter, outlining steps taken to correct these violations and provide supporting documentation. Failure to comply may result in enforcement actions, including product seizure and/or injunction.