Dr Reddy's Miryalaguda plant observations minor: Edelweiss

Drug maker Dr Reddy’s Laboratories, last month said that it got three Form 483 observations from US FDA, for its Miryalaguda API plant in Telangana. The company didn’t explain the nature of these observations but said that they are addressable and is responding to it. Moneycontrol has reported speaking to company executives and external consultants that the observations are minor and can be correctable. Read more The plant was inspected by USFDA from February 13-21.Miryalaguda plant called at CTO Unit V was one among the three plants for which the company received US drug regulator warning letter in November 2015. The warning letter mentioned deviations in good manufacturing practices such as failure to adequately investigate out-of-specification results and implement appropriate corrective actions; failure to maintain all quality-related documents appropriately; failure to prevent un-authorised access or changes to data and failure to identify storage containers for intermediates in batch production records.Miryalaguda plant supplies active ingredients for company’s captive consumption as well as for its customers. According to Edelweiss Research note the three observations made US FDA on Miryalaguda plant relates to deviations on deficiency of test methods, procedures describing the calibration of instruments and certain recording keeping practices.Below are the three observations:1. The specificity of test methods has not been established. Here agency highlighted that company failed to do stress studies in certain case and in other case the data supporting the validation activities was found to be inadequate and incomplete.2. Procedures describing the calibration of instruments are deficiently written or followed. Here agency highlighted the calibration of GC was incomplete and microbalance was outside its calibration range.3. Records maintained of any modification of an established method employed in testing do not include the reason of modification, the data to verify that modification produced results that are at least as accurate and reliable for the material being tested as the established method. Then agency provided the particular instances where this lapse happened.Edelweiss said the observations on API plant at Miryalguda "looks minor in nature and company should be able to resolve it".