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.;
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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.
"This warning letter summarises significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals ...Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated," the USFDA said.
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. "Your firm manufactures sterile injectables and solid dosage drug products. You failed to conduct adequate out-of-specification (OOS) and complaint investigations, including the identification of the root cause and timely implementation of effective corrective action and preventive action (CAPA) plans," the USFDA noted.
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