FDA Sends Warning Letter to Pennsylvania Facility

FDA sent a warning letter, dated Oct. 28, 2019, to Torrent Pharma after an inspection of the company’s Levittown, PA facility found deviations from current good manufacturing practices. During the inspection, which was conducted from March 11–April 9, 2019, FDA investigators found that the company’s water system was inadequate, and it had failed to properly investigate failing microbiological results from its water system.

In the letter, the agency stated that the water system had sanitary design deficiencies, such as dead legs and threaded pipe connections. “Notably, your firm isolated Burkholderia cepacia from manufacturing equipment rinse samples. 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,” FDA stated in the letter.

In response to the agency’s observations, the company decided to decommission its water system and replace it with a temporary system until a new permanent system could be installed. FDA stated in the warning letter that the company did not provide measures to ensure the water generated from the temporary system would meet quality standards, nor did the company provide details about the design of either the temporary system or the new system. FDA requested the company provide an assessment of the design of both its water systems, a program for ongoing control and maintenance of the water system, a corrective action and preventive action (CAPA) plan, validation reports for the new water system, and a list of products made using the temporary water system.

In response to the company’s lack of appropriate investigations of deviations, FDA requested it provide an independent assessment of its overall system for investigating out-of-specification results and failures. The agency also requested a detailed CAPA plan to remediate the investigation system and to implement management oversight of facilities and equipment.

Source: FDA