FiercePharma

FDA flags 10 observations in another Form 483 for a Zydus plant

Zydus Lifesciences recently received its second Form 483 reprimand from the FDA within the span of one month. In the second write-up, the regulatory agency flagged issues ranging from unqualified ...
FiercePharma

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

Roughly a year after receiving an FDA reprimand at its manufacturing plant in Michigan, Indian drugmaker Piramal Pharma has landed in the regulator’s crosshairs once again. Following an inspection of ...
MD&M East

That Time FDA was ‘Unusually Thorough’ on a Form 483

Having noticed an uptick in medical device recalls and FDA warning letters to medtech companies this year, it seems an appropriate time to look back on a Form 483 from December 2016 that surprised ...
Hosted on MSN

Dr Reddys Labs' manufacturing facility gets two form 483 observations from US FDA

Mumbai, May 26 -- In a regulatory filing made on Saturday (24 May 2025), the company informed that the US FDA had conducted a GMP inspection at its API manufacturing facility in Miryalaguda, Telangana ...
Hosted on MSN

NATCO Pharma's Hyderabad-based plant gets 'one' Form 483 observation post US FDA audit

Mumbai, June 14 -- On conclusion of the inspection, the company received one observation in the Form-483. The company believes that the observation is procedural in nature. The company is confident to ...