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.
"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," it added.
The Hyderabad-based company manufactures angiotensin II receptor blockers (ARBs) including valsartan, telmisartan, and olmesartan API and intermediates for non-US supply chains.
"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 USFDA said.
The USFDA asked the firm to initiate a comprehensive, independent assessment of its overall system for investigations of deviations, atypical events, complaints, out-of-specification results, and failures.
The US health regulator also pointed out failure of the company to have adequate cleaning procedures to prevent contamination or carry-over of a material that would alter the quality of the API.
It also said Lantech failed to control and monitor procedures to recover solvents to ensure that they meet appropriate standards before reuse.
Besides, the company failed to exercise sufficient controls over computerised systems to prevent unauthorised access or changes to data and failure to have adequate controls to prevent omission of data, USFDA said.
"Your firm failed to implement adequate controls to ensure the integrity of data generated at your facility," it noted.
The health regulator said it strongly recommends the company to engage a consultant to assist the firm in meeting CGMP requirements.
Until all corrections have been completed and FDA has confirmed corrections of the violations and the firm's compliance with CGMP, FDA may withhold approval of any new applications or supplements, it added.
In addition, the company's failure to correct these violations may result in FDA continuing to refuse admission of articles manufactured at the plant into the US, the regulator added.
The FDA issued the letter on August 8, and has given the company 15 days to respond. Lantech could not be reached immediately for comments over the FDA letter.