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FDA issues warning letter to Lantech Pharma
American health regulator USFDA has pulled up Lantech Pharmaceuticals for violation of current good manufacturing practice norms, including failure to investigate presence of a carcinogen in a solvent, at its Andhra Pradesh-based manufacturing plant.
New Delhi: American health regulator USFDA has pulled up Lantech Pharmaceuticals for violation of current good manufacturing practice norms, including failure to investigate presence of a carcinogen in a solvent, at its Andhra Pradesh-based manufacturing plant.
In a warning letter issued to the company's Managing Director V Prakash Reddy, the USFDA said inspectors during March 6-15 this year found significant deviations from standard manufacturing practices at the company's Ranastalam (Srikakulam district) based plant.
"This warning letter summarises significant deviations from CGMP for active pharmaceutical ingredients (API) because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated," the US Food and Drug Administration (USFDA) said.
The significant violations included failure of the quality unit to ensure that quality-related complaints were investigated and resolved, it noted.
The USFDA said that in December 2018, a customer had notified the company about the presence of a potential mutagenic impurity, N-Nitrosodiethylamine (NDEA) in one of the solvents.
