USFDA flags cleanliness, procedural issues at Dr Reddy's Bachupally unit in Hyderabad

According to the exclusive documents accessed by CNBC TV 18, the regulator spotted cleanliness and procedural lapses in the plant

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The US Food and Drug Administration (USFDA) has flagged cleanliness and procedural issues in its observations letter to Dr.Reddy’s Laboratories according to a CNBC TV18 report.

Earlier, Dr Reddy's Laboratories Ltd said the USFDA has issued a Form 483 with 10 observations for its biologics manufacturing facility located in Hyderabad's Bachupally.

The company’s Bachupally manufacturing plant was inspected by the USFDA between October 19 and October 27. The inspection was a routine cGMP inspection at the company's formulations manufacturing facility (FTO-3).

According to the exclusive documents on the observations, the regulator spotted cleanliness and procedural lapses in the plant. It said that “equipment & utensils not cleaned & maintained at appropriate intervals,” and that “procedures applicable to quality control are not followed”.

The regulator also noted that appropriate controls were not exercised over computers or related systems, and the accuracy of test methods has not been established. It was identified that the use of instruments did not meet their established specifications.

Also read: Dr Reddy’s Hyderabad manufacturing plant receives 9 US FDA observations

The report also identified procedural errors in quality control and noted relaxed specifications. It said that the plant failed to review discrepancies in batch distribution and that procedures with respect to complaints for drug products were not written properly.

The regulator also expressed concerns over cleanliness at the manufacturing plant. It stated that the drug manufacturing & processing building was not maintained in a good state. It further noted that the plant failed to establish procedures designed to assure drug purity & quality.

Dr. Reddy's, on October 27, released its second-quarter earnings for the current fiscal and recorded its highest-ever consolidated net profit of Rs 1,480 crore, marking a 33 percent increase from the same period last year when it reported a profit of Rs 1,112.80 crore.