Dr. Reddy's solid dose plant pinched by FDA for missteps

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.
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