Drugmaker Cipla announced that it has received a warning letter from the United States Food and Drug Administration (USFDA) following an inspection earlier this year at its Pithampur site, Indore (Madhya Pradesh).
The USFDA warning letter, dated November 17, 2023, follows a routine current Good Manufacturing Practices (cGMP) inspection at the Pithampur manufacturing facility, undertaken between February 6 and 17, 2023, the company told BSE.
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“This Warning Letter summarises 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,” Cipla said, adding that it would respond within the stipulated time and comply.
The site manufactures the company’s inhalers, among other things, and played a crucial role in the launch of its generic Advair in the US. However, given the regulatory action, Cipla’s management has indicated in analyst and media interactions that they were derisking the process and transferring the product to another site.