FDA dings Piramal API plant with Form 483 detailing problems tied to quality control, equipment cleaning and more

26th February 2025 Uncategorised 0

Following an inspection of Piramal’s production facility in Maharashtra, India, that ran from Feb. 11 to Feb. 17, the FDA slapped the company with six-observation Form 483 detailing shortfalls related to quality control, written records, equipment maintenance and more. The writeup comes after Piramal received a separate Form 483 at a site in Michigan last February.

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Source: fierce