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Glenmark gets five observations from USFDA for Pithampur facility

Glenmark gets five observations from USFDA for Pithampur facility

Glenmark gets five observations from USFDA for Pithampur facility
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By Ekta Batra  Jun 6, 2018 11:01:52 AM IST (Updated)

The CNBC-TV18 on Tuesday has accessed Form 483 with five observations issued to Glenmark Pharmaceuticals Ltd's Pithampur facility by US Food and Drug Administration (US FDA).

CNBC-TV18 on Tuesday has accessed Form 483 with five observations issued to Glenmark Pharmaceuticals Ltd's Pithampur facility by US Food and Drug Administration (USFDA).

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The FDA representatives had inspected the facility between May 14 and 24.
Form 483 is issued to a company when investigators find violations of the Food Drug and Cosmetic (FD&C) Act and related acts during an inspection.
Five observations are as follows:
  • Accuracy, sensitivity, specificity, reproductability of test methods not established and documented.
  • Lab controls do not include establishment of scientifically sound and appropriate sampling plans.
  • Failure to thoroughly review any unexplained discrepancy whether or not batch has already been distributed.
  • Appropriate controls not exercised over computers or related systems.
  • Responsibilities and procedures applicable to quality control not fully followed.
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