The warning letter by FDA has summarized and analyzed several of Prosana’s significant violations. One of the most interesting inspectional observations or violations of CFR21 part 211 is the fact that the company has failed to follow Quality Agreements under 21 CFR part 211.65 regulation. According to FDA’s policies, drug companies are obligated to receive the certificate of analysis, of COA, before they decide to distribute the batches of products. Prosana’s management, in turn, has received COAs for Bicaruvas batches EBU02 and EBU03 after these batches had been distributed to the US. Moreover, the company used a third-party testing laboratory to inspect the products.
The company’s misbranding violations include its failure to provide the information required under the authority of the FD&C Act in both English and Spanish, even though the labeling includes both of these languages. The misbranding activities also involved violations under section 502(c) of the FD&C Act, 21 U.S.C. 352(c), since there were not enough control numbers and expiration dating included in the outer carton nor the individual packets. In addition, the company has introduced a misbranded drug into interstate commerce, which is considered to be a violation under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). Thus, it can be concluded that the company is responsible for several serious misbranding violations.
Having received the warning letter, Prosana management should notify the FDA office in writing of the steps the company has taken or will be taking to correct the cited violations within 15 working days. In case the company is not able to take corrective measures in that period, it has to inform the FDA office about the reasons for the delay and provide a new schedule for completion.