Sanitation and Procedural flaws at Dr. Reddy's Bachupally Plant in Hyderabad

By Consultants Review Team Wednesday, 15 November 2023

The US Food and Drug Administration (USFDA) has identified cleanliness and procedural concerns in its observations letter to Dr.Reddy's Laboratories. Earlier, Dr Reddy's Laboratories Ltd announced that the USFDA had issued a Form 483 with 10 remarks for its biologics production plant at Bachupally, Hyderabad.

The USFDA investigated the company's Bachupally manufacturing factory between October 19 and October 27. A routine cGMP inspection was performed at the company's formulations manufacturing plant (FTO-3). The regulator observed cleanliness and procedural shortcomings in the plant, according to the unique documents on the observations. It went on to say that "equipment & utensils not cleaned & maintained at appropriate intervals," as well as the "procedures applicable to quality control are not followed." 

The regulator also stated that suitable controls over computers or related systems were not implemented, and the accuracy of test techniques was not established. It was discovered that the instruments used did not fulfill their specified specifications.

The audit also highlighted quality control procedural flaws and flagged lowered standards. It said that the plant failed to review discrepancies in batch distribution and that procedures concerning complaints for drug products were not written properly.

The regulator was also concerned about the manufacturing plant's cleanliness. It was reported that the medicine manufacturing and processing building was not kept in excellent condition. It further stated that the plant failed to create procedures to ensure medicine purity and quality.

Dr. Reddy's declared its second-quarter earnings for the current fiscal year on October 27 and reported its highest-ever consolidated net profit of Rs 1,480 crore, a 33% rise over the same period last year when it earned a profit of Rs 1,112.80 crore.


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