USFDA is suing Natco Pharma for several violations at its Telangana plant
Natco Pharma failed to maintain hygiene at its Telangana plant and sterilize equipment and utensils at appropriate intervals, the US health regulator said.
In the warning letter to the company, the US Food and Drug Administration said its investigators observed several violations at the completed pharmaceutical factory at Kothur Village in Telangana.
The USFDA inspected the facility from October 9 to 18, 2023.
“Your company has failed to clean, maintain and, as appropriate to the nature of the drug, disinfect and/or sterilize equipment and utensils at appropriate intervals to prevent malfunction or contamination that could affect safety, would impair the identity, potency, quality or purity of the medicinal product beyond official or other established requirements,” the US health regulator noted.
It went on to say: “Your cleaning procedure for your non-specific equipment is inadequate.” Cross-contamination is not uniform, and testing of control samples and placebo batches could not scientifically prove that products are free of contaminants from visibly contaminated equipment, the USFDA said.
“You are not adequately addressing the contamination found on product contact surfaces, and you are not recognizing 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 discrepancies or failure of a batch or any of its components to meet specifications, regardless of 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 results, discrepancies, errors, and records management system.
Provide a report that evaluates whether staff have appropriate investigative competencies, effectively conducts root cause analysis and ensures the effectiveness of corrective and preventive action (CAPA), the report said.
“We recognize your commitment to temporarily suspend production of all drugs manufactured on all specialty and non-specific equipment for the U.S. market while you remediate the CGMP violations,” it added.
If the drug manufacturer plans to resume manufacturing operations, you must notify this office before resuming production, the USFDA said.
A warning letter is issued when the U.S. health regulator finds that a manufacturer has significantly violated its regulations.
India has the largest number of USFDA compliant pharmaceutical factories outside the US.
According to a report, the country has more than 600 USFDA-registered manufacturing sites, accounting for nearly 12.5 percent of all registered manufacturing sites operating outside the US.
(Only the headline and image of this report may have been reworked by Business Standard staff; the rest of the content is automatically generated from a syndicated feed.)
First print: April 21, 2024 | 11:33 am IST