The United States Food and Drug Administration has observed seven quality lapses at Mumbai-based pharmaceutical company Glenmark’s Baddi unit in Himachal Pradesh, Mint reported on Tuesday. The US regulator had inspected the unit between November 6 and November 11.
The US FDA issued a Form 483, citing seven observations relating to violation of good manufacturing practices. The regulator issues this form if it feels that a company’s actions may constitute violations of the US Food Drug and Cosmetic Act.
Mint reported that the observations made by the US FDA include “no thorough review of discrepancy in drug batches, lack of written procedures to assure identity and strength of products, lack of complaint records, inadequate maintenance of records to evaluate quality standards of each drug, insufficient adherence to procedures of the quality control unit, inappropriate controls over computers and lack of proper training to employees.”
“We are in the midst of providing a comprehensive response to the observations and would be replying to the FDA shortly,” Glenmark said in a BSE filing. The company added that the Baddi unit contributes approximately 10% of the revenue of its US sales.
Shares of the pharmaceutical firm fell steadily throughout the trading day following the FDA’s observations. The company’s stocks ended 3.28% lower on Tuesday.
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