US FDA Warning Letters And Indian Pharma

Greater emphasis on quality will allow India to participate more fully in existing global venues such as the International Council for Harmonisation (ICH) and the Pharmaceutical Inspection Cooperation Scheme (PIC/S) – which will enable stronger collaboration and synergies among regulators. Quality is good for economic development, the market, and most importantly, patients and consumers everywhere.

- Narayan Kulkarni

On April 28, 2017, Vikshara Trading & Investments Ltd, from Gujarat has received warning letter from US Food and Drugs Administration (FDA). The US FDA during its inspection of its facility at Anup Engineering, Odhav Road, Ahmedabad on October 18, 2016, noted that its investigator documented that the firm delayed and limited an FDA inspection.

The US FDA noted that under the FD&C Act, as amended by the Food and Drug Administration and Innovation Act (FDASIA), section 707, 21 U.S.C. 351(j), the drugs are adulterated in that they have been manufactured, processed, packed, or held in an establishment where the owner or operator has delayed and/or limited an inspection.

This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. Because of the methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, the company’s drugs are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

The US FDA has concluded that the violations cited in this letter are not intended as an all-inclusive list. The company is responsible for investigating these violations, for determining the causes, for preventing their recurrence, and for preventing other violations. The FDA placed the firm on Import Alert 66-40 on February 8, 2017, and on Import Alert 99-32 on February 9, 2017.

The FDA further observed that until the company corrects all violations completely and it confirms their compliance with CGMP, FDA may withhold approval of any new applications or supplements listing the firm as a drug manufacturer. Failure to correct these violations may also result in FDA continuing to refuse admission of articles into the United States.