USFDA Flags Cleanliness and Procedural Issues at Dr. Reddy's; 10 Observations Issued

15 Nov 2023 , 01:12 PM

The USFDA issues Form 483 with 10 observations to Dr. Reddy’s Laboratories, highlighting cleanliness and procedural issues, as reported by CNBC TV18. The observations stem from a routine cGMP inspection at Dr. Reddy’s formulations manufacturing facility (FTO-3) in Bachupally, Hyderabad, conducted between October 19 and October 27.

Exclusive documents reveal the regulator’s concerns, including cleanliness and procedural lapses such as equipment not cleaned at appropriate intervals and non-compliance with quality control procedures. The USFDA identifies issues with controls over computers and related systems, questioning the accuracy of test methods and instruments not meeting established specifications.

Procedural errors in quality control, relaxed specifications, failure to review batch distribution discrepancies, and inadequacies in procedures for drug product complaints are among the noted observations.

The regulator expresses concerns about the manufacturing plant’s cleanliness and maintenance, emphasizing the need for procedures ensuring drug purity and quality. Dr. Reddy’s, in its second-quarter earnings released on October 27, reports the highest-ever consolidated net profit of Rs 1,480 crore, reflecting a 33% increase from the same period last year.

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