The USFDA inspected the facility from October 9 to 18, 2023.
“Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize 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 product beyond the official or other established requirements,” the US health regulator noted.
It further said: “Your cleaning procedure for your non-dedicated equipment is inadequate.” Cross-contamination is not uniform, and the testing of control samples and placebo batches failed to scientifically prove that products are free of contaminants from visibly dirty equipment, USFDA stated.
“You do not sufficiently address contamination recovered from product contact surfaces, and you fail to acknowledge that other locations and other sampling may reveal high levels of contamination,” it added.
The US health regulator further stated that 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. The USFDA sought a comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, out-of-specification (OOS) results, discrepancies, failure, and records management system. Provide a report that evaluates whether staff possesses proper investigation competencies, effectively conducts root cause analysis, and assures a corrective action and preventive action (CAPA) effectiveness, it said.
“We acknowledge your commitment to temporarily suspend production of all drugs manufactured on all dedicated and non-dedicated equipment for the US market while you remediate the CGMP violations,” it added.
If the drug maker plans to resume any manufacturing operations, notify this office before resuming production, USFDA said.
A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations.
India has the highest number of USFDA compliant pharma plants outside of the US.
As per a report, the country has more than 600 USFDA registered manufacturing sites, constituting nearly 12.5 per cent of all registered manufacturing sites operating outside the US.
