For violation of current good manufacturing practice norms, including failure to investigate the presence of a carcinogen in a solvent USFDA has pulled up Lantech Pharmaceuticals at its Andhra Pradesh-based manufacturing plant.
At the company’s Ranastalam (Srikakulam district) based plant, the inspectors found significant deviations from standard manufacturing, said the USFDA in a warning letter issued to the company’s Managing Director V Prakash Reddy.
The US Food and Drug Administration (USFDA) said, “Significant deviations from CGMP for active pharmaceutical ingredients (API) are summarized in this warning letter.
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated.”
It noted that the failure of the quality unit was included in the significant violations to ensure that quality-related complaints were investigated and resolved. It further adds, “Your firm opened an investigation. However, your investigation was inadequate. The scope of your investigation failed to include non-dedicated storage, receiving, and charging tanks used in your solvent recovery operations.”
The USFDA said, “Your firm failed to adequately evaluate the potential of these ARBs to form nitrosamines and identify potential cross-contamination risks for drugs manufactured made using non-dedicated equipment and shipped into the US supply chain.”
The firm was asked to initiate a comprehensive, independent assessment of its overall system for investigations of deviations, atypical events, complaints, out-of-specification results, and failures by the USFDA.
Furthermore, the USFDA said that the company failed to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data and failure to have adequate controls to prevent omission of data.