USFDA pulls up Cipla for manufacturing lapses at Pithampur plant
Source: EconomicTimes
A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations. “Your firm failed to thoroughly investigate any unexplained 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 stated in the letter.
The US health regulator has pulled up drug major Cipla for various manufacturing lapses at its Pithampur (Madhya Pradesh) based manufacturing facility. In a letter to the company’s Managing Director Umang Vohra, the US Food and Drug Administration (USFDA) stated that it inspected Cipla’s Pithampur-based plant in Madhya Pradesh during February 6-17, 2023.
“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,” it noted.
“Your firm failed to thoroughly investigate any unexplained 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 stated in the letter.
It also pointed out the company’s failure 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 sterilization processes.
“Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures,” it added,
USFDA noted that it has cited similar CGMP observations earlier at company’s other facilities as well.
“Your executive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance. Executive management should immediately and comprehensively assess your company’s global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements,” it stated.
