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USFDA warning letter to Anicare Pharmaceuticals

Updated: 28 February 2019

The FDA inspection at Navi Mumbai facility of Anicare Pharmaceuticals was done during 30 July 2018 to 03 August 2018. The company has received warning letter following this audit due to cGMP violations at their facility for finished pharmaceuticals.

It has been stated that their drug products are adulterated as per section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B) because manufacturing controls, packing, facilities, methods and processing does not meet the cGMP regulations. The company is involved in manufacturing of several over-the-counter drug products such as Budpak Feminine Anti-itch cream, U First Aid Cream which are considered as misbranded as per sections 502(c) and (x) of the FD&C Act, 21 U.S.C. 352(c) and (x). Such products are prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Appropriate written testing program related with stability characteristics of drug products has not been established and followed and there was no program related with expiration dates and stability conditions. Written procedures for process control and production were not reviewed and approved by quality control team. Validation studies were not effectively done for the drug products. Adequate written procedures for equipment cleaning and maintenance were also not established and followed by the company.

Thus, it can be concluded that the firm has no adequate process to establish and follow written procedures for different manufacturing processes. It leads to receiving of warning letter for their facility and approval withhold of any new drug.