In a warning letter issued to Torrent Pharma Inc's CEO Sanjay Gupta, the US Food and Drug Administration (USFDA) 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 USFDA 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 USFDA noted.
The plant's water system was not adequately designed, controlled, maintained, and monitored to ensure it consistently produced water that met specifications and appropriate microbial limits, it added.
"An investigation identified your water system as the source of the contamination. Subsequent sampling of your water system revealed an adverse pattern of B. cepacia contamination in your pretreatment and downstream distribution system," the health regulator noted.
Elaborating, USFDA said that pharmaceutical water must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate microbiological attributes.
"Systems that produce water for manufacturing and cleaning are critical determinants of the quality and safety of your drug products. Your firm produced drug products such as rectal suppositories and oral solutions with this inadequate water system," it said.
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, USFDA added.
"You lacked an adequate investigation into failing microbiological results from your water system," it noted in its letter dated October 28.
The US health regulator did not approve of the resolutions brought in by the drug maker at the facility, terming the steps as inadequate.
"Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant to assist your firm in meeting CGMP requirements," it added.
Until all corrections have been completed and USFDA has confirmed corrections of the violations and the firm''s compliance with CGMP, the regulator may withhold approval of any new applications or supplements, it said.
In addition, the company's failure to correct these violations may result in USFDA continuing to refuse admission of articles manufactured at the plant into the US, it added. MSS SR ABM ABM