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25th November 2019  Author: Paul Carton

FDA Issue Warning to Pharma Plant for Adverse Burkholderia cepacia Levels in Water System

 "'Dead-legs and threaded-pipe connections" in the water system with "an adverse pattern of Burkholderia cepacia found in pretreatment and downstream distribution system"  were some of the failures the US Food and Drug Administration (FDA) found during an inspection at the Torrent Pharma Inc. drug manufacturing facility in Levittown, Pennsylvania. 

The inspection was carried out from March 11th to April 9, 2019, and an FDA form 483 was issued to the company, which is standard protocol when an investigator observes conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act. Upon receiving this form and its following correspondence from the plant on how they planned to rectify matters, the FDA Office of Pharmaceutical Quality (OPQ) sent a warning letter on Oct 28th, 2019 in response. It informed the pharmaceutical company that they violated CFR 211.63 ( Current Good Manufacturing practice- Equipment design, size and location) by producing rectal suppositories and nasal and oral solutions with this inadequate water system. 

One of the measures taken by Torrent Pharma to improve the water system was to decommission the faulty one and replace with a temporary system until a permanent one is installed. However, the OPQ was unsatisfied with the amount of information supplied by Torrent about this temporary water system in regards to its validation and how microbiological contamination in water will be monitored. The FDA demand Torrent Pharma to provide validation reports for new water systems, a thorough corrective action and preventive action (CAPA) plan and a program for ongoing control and maintenance. 

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Date Published: 25th November 2019

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