The US Food and Drug Administration (USFDA) has issued a warning letter to drug major Cipla for violating current good manufacturing practice norms at its Goa-based plant.
In a letter to company's Managing Director and Global CEO Umang Vohra, the USFDA said inspectors during September 16-27, 2019, had found significant deviations from standard manufacturing practices at Cipla's Goa (Verna) based plant.
"This warning letter summarises significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals...because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated," the USFDA said.
The significant violations included company's failure "to clean, maintain, and, as appropriate for the nature of the drug, sanitise and/or sterilise equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug," it added.
The USFDA said the company's cleaning procedure for non-dedicated equipment, including equipment is inadequate.
"Our investigators observed multiple containing residues of what appeared to be different products inside the exhaust ducts. Analytical testing conducted by your firm on the residues collected from this manufacturing equipment confirmed the presence of multiple active ingredients," it added.
Besides, the company failed to thoroughly investigate any discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed, USFDA noted.
"Your firm failed to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes," it added.
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at the company's facility, USFDA said.
"You are responsible for investigating and determining the causes of these violations and for preventing their recurrence or the occurrence of other violations," he added.
Until all corrections have been completed and FDA has confirmed corrections of the violations and the firm's compliance with CGMP, FDA may withhold approval of any new applications or supplements, the USFDA said.
In addition, the company's failure to correct these violations may result in FDA continuing to refuse admission of articles manufactured at the plant into the US, it added.
The FDA issued the letter on February 25, and had given the company 15 days to respond.
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