Scottish Company Receives USFDA Warning Letter

FDA issued a warning letter, dated Sept. 29, 2016, to Wallace Cameron International regarding drugs shipped to the United States from the company’s Wishaw, Scotland facility. The letter stated that the facility was not registered properly for 2016 in compliance with the US Federal Food, Drug, and Cosmetic Act (FD&C Act).

According to FDA, the FD&C Act requires companies engaged in the manufacture, preparation, propagation, compounding, or processing of a drug that is imported into the US to submit registration information on each foreign establishment owned or operated. FDA stated in the warning letter that the agency had notified the company in March 2016 that it was not registered. “Our records indicate you have not availed yourself of this opportunity to register or list,” FDA stated. “In addition, your firm’s failure to fulfill its establishment registration and drug listing obligations misbrands the product under Section 502(o) of the FD&C Act. Introduction or delivery for introduction into interstate commerce of a misbranded product is a prohibited act under Section 301(a) [21 U.S.C. 352(o) and 331(a)].”