US FDA issues warning letter to Torrent Pharma arm for violations of GMP
The United States Food and Drug Administration (FDA) has issued a warning to drug maker Torrent Pharmaceuticals 'US-based subsidiary for violations of good manufacturing practices.
In a warning letter issued to Torrent Pharma Inc's CEO Sanjay Gupta, the US Food and Drug Administration (FDA) said its inspectors found significant violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals at the company's Levittown (Pennsylvania) based manufacturing facility.
The US FDA inspected the plant from March 11 to April 9 this year
"Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance," the US FDA noted.
US FDA in its letter dated October 28 stated that pharmaceutical water must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate microbiological attributes.
Besides, the company failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed, it said.