The FDA keeps rolling through the Indian manufacturing plants of Dr. Reddy’s Laboratories and the Form 483s keep falling out.
The FDA this week posted a Form 483 (PDF) for the Dr. Reddy’s solid dose plant in Pradesh that was issued after an inspection in January. There were only four observations, but they covered missteps in some of the basic tenets of quality manufacturing.
The highly redacted Form 483 said that the plant did not do nearly enough to investigate out of spec analysis when stability batches were found to contain impurities. It said the plant had not thoroughly tested the API from the supplier and did not test finished products for the uniformity of impurities in process validation. The inspectors said plant did not extend an investigation into an out of spec tablet batch to see if previously released batches might have the same issue.
There were also computers and electronic equipment that were not properly password protected. There was no procedure for an operator to take action when an equipment alarm went off during production nor for another operator to report an oil leak he saw in a piece of equipment that was not operating at the time.
This is more of the same for Dr. Reddy’s, which this month also reported the FDA had issued a Form 483 for its formulations plant in Bachupally that included 11 observations, four of them repeats.
India’s second-largest drugmaker did have one important turn of events recently in its struggle to get all of its plants up to FDA expectations. It reported that the FDA had notified it that the steps it has taken to improve operations at its long-troubled oncology formulations plant in Duvvada, India, have finally satisfied the agency. The agency reclassified it as “Voluntary Action Initiated (VAI),” Dr. Reddy’s reported.
The Duvvada facility was one of three plants named in a sweeping FDA warning letter more than three years ago. Follow-up inspections in 2017 and again last October again noted problems.