USFDA raises concerns over cleanliness and procedures at Dr. Reddy's Hyderabad facility
Dr. Reddy's Laboratories Ltd received a Form 483 from the US Food and Drug Administration (USFDA) with 10 observations for its biologics manufacturing facility in Hyderabad's Bachupally.
USFDA Raises Concerns Over Cleanliness and Procedures at Dr. Reddy's Hyderabad Facility
Dr. Reddy's Laboratories Ltd received a Form 483 from the US Food and Drug Administration (USFDA) with 10 observations for its biologics manufacturing facility in Hyderabad's Bachupally. Exclusive documents accessed by a reputed media group revealed that the USFDA highlighted cleanliness and procedural lapses during its routine cGMP inspection between October 19 and October 27.
The observations cited issues such as equipment and utensils not being cleaned and maintained at appropriate intervals, deviations in quality control procedures, lack of control over computers and related systems, and instruments not meeting established specifications.
Additionally, procedural errors in quality control and concerns about the manufacturing plant's cleanliness were noted. Despite these issues, Dr. Reddy's recently reported its highest-ever consolidated net profit of Rs 1,480 crore for the second quarter of the current fiscal year.
