The US health regulator has pulled up Kilitch Healthcare India for manufacturing lapses, including packing drugs in insanitary conditions at its Maharashtra-based plant.
In a warning letter to the company's Managing Director Paresh Mehta, the US Food and Drug Administration (USFDA) pointed out various lapses at the Navi-Mumbai plant, which produces finished pharmaceuticals.
The warning letter summarises significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, the US health regulator said. "Because your drug products were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health," it stated.
"FDA investigators observed your facility to be in a state of disrepair, poorly cleaned and maintained." A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations.
It usually identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. The letter also makes clear that the company must correct the problem and provides directions and a timeframe for its plans for correction.
The regulator then checks to ensure that the company's corrections are adequate. The USFDA inspected Kilitch Healthcare's Navi-Mumbai-based plant on October 12-20, 2023.
Elaborating on the CGMP violations at the facility, the USFDA stated that the company failed to establish and 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 sterilisation processes. "Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards," it added.
The USFDA also said the plant administration to collect the required amount of environmental and personnel monitoring samples required to support the manufacture of sterile drug products. "Your environmental monitoring (EM) program is deficient," it added.
The regulator also asked the company to have a comprehensive investigation into the extent of the inaccuracies in data records and reporting. "We acknowledge your commitment to suspend production of all drugs for the US market. In response to this letter, clarify whether you intend to resume manufacturing drugs for the US market at this facility in the future," the USFDA said.
"FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any deviations," it added. The health regulator further stated that the warning letter notifies the company of its findings and provides an opportunity to address the above deficiencies.
"After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any deviations and to prevent their recurrence," it added.
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