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Shilpa Medicare gets USFDA warning for CGMP violations at Telangana unit
The significant violations included the company's failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications.
New Delhi: The US Food and Drug Administration (USFDA) has issued a warning letter to Shilpa Medicare for violating current good manufacturing practice norms at its manufacturing plant in Mahabubnagar district in Telangana. In a letter to company's Managing Director Vishnukant Chaturbhuj Bhutada, the US health regulator said its inspectors, from February 13-20 and February 24-25, 2020,...
New Delhi: The US Food and Drug Administration (USFDA) has issued a warning letter to Shilpa Medicare for violating current good manufacturing practice norms at its manufacturing plant in Mahabubnagar district in Telangana.
In a letter to company's Managing Director Vishnukant Chaturbhuj Bhutada, the US health regulator said its inspectors, from February 13-20 and February 24-25, 2020, found significant deviations from standard manufacturing practices at company's Unit-IV at Polepally village in Mahabubnagar district.
Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751