Drug Approval | December 25, 2023
Eugia's East Windsor facility gets 10 observations from USFDA
The plant is yet to start commercial operations
The plant is yet to start commercial operations
This PAI-cum-GMP USFDA inspection was conducted from December 14 to December 22, 2023
Granules Pharmaceuticals gets 5 observations from USFDA on completion of GMP inspection
Laurus Synthesis receives Form 483 with 5 observations from USFDA
Expansion of presence in India with electrical safety, electromagnetic compatibility and medical device biocompatibility, toxicity and microbiology testing and certification services
Dr. Reddy's Laboratories has been issued a Form 483 with three observations
The inspection of the facility conducted from August 7 to August 11, 2023
The company is confident of addressing all the observations within the stipulated time
The USFDA inspectors issued the observations after a product pre-approval inspection of the biologics facility in Bachupally
The company had submitted a comprehensive Corrective and Preventive Action (CAPA) plan in September 2022
Subscribe To Our Newsletter & Stay Updated
