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