The American agency conducted a routine inspection at the facility in February.
“We wish to inform you that on November 18, 2023, the company has received a warning Letter dated November 17, 2023 from [the] United States Food and Drug Administration (USFDA) for the routine current Good Manufacturing Practices (cGMP) inspection conducted at our Pithampur manufacturing facility between February 6-February 17, 2023,” Cipla said in an exchange filing.
According to the filing, the drug manufacturer was given a detailed breakdown of the lapses in methods followed at the facility by the USFDA.
“This warning letter summarizes contraventions regarding methods or controls followed at the facility which do not conform to the prescribed cGMP regulations and contains directional guidance for necessary corrections,” the filing said.
Cipla further said in the filing that it would be working with the American agency to ensure that the problems at the Pithampur plant are fixed. “The company will respond to the warning letter within the stipulated timelines and work closely with the USFDA to address the concerns in a holistic and timely manner to ensure sustained compliance,” reads the filing. “We uphold quality and compliance with utmost importance and remain committed to be compliant with the cGMP quality standards,” the company added.
Cipla’s shares closed at Rs 1,234.80 on Friday, November 17.
