The U.S. Food and Drug Administration (USFDA) has warned Indian generic drug-maker Emcure Pharmaceuticals of serious violations of the current good manufacturing practice (CGMP) regulations at one of its manufacturing plants in Pune, Maharshtra.
The USFDA in its warning letter, dated March 3, said the violations lead to the adulteration in Emcure Pharma's products.
"We identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. These violations cause your drug products to be adulterated under the Federal Food, Drug, and Cosmetic Act," the USFDA letter addressed to Emcure Pharma read.
According to the letter, the methods used in the manufacture, processing, packing, or holding of drugs do not conform to the rules under the CGMP.
The U.S. regulator said due to the poor drug handling techniques at its manufacturing facilities by the Emcure Pharma's operators, the company products, especially the injectible drugs, could be contaminated.
The Emcure Pharma's facility design, according to the FDA, represents an additional risk of contamination to the products. The regulatory body also notified about the company's laboratory set up and testing procedures.
"Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity."
The USFDA also warned Emcure Pharma of various other violations, including data falsification and manipulation, reliance on incomplete records for product release in 2014.
The drug regulator asked Emcure Pharma to respond within 15 working days of receipt of the warning letter.
