Torrent Pharma receives Form 483 for unclean equipment
The inspection took place between September 9-28 and was conducted in Indrad, Gujarat, at a finished product and active pharmaceutical ingredient (API) plant.
According to the company, the facility covers approximately 1,005,757-square-meters and has an annual capacity of 30 million vials, 5.5 billion tablets and capsules, and 45 metric tons of API.
The US Food and Drug Administration (FDA) noted during its visit that there were issues with the cleaning of the equipment and utensils used to produce drug product, which constituted its first observation.
More specifically, the Form 483 outlines, “Your manual cleaning procedure for non-dedicated manufacturing equipment is inadequate in that does [sic] not ensure the removal of residues from the previously manufactured product to avoid cross-contamination”.
The agency provided an example where white powder residue was observed on different surfaces of a manufacturing suite that had been marked as cleaned. The inspector continued to note that the analytical cleaning method used to monitor the effectiveness of the manual cleaning process was inadequate.
The second observation was related to a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications. The third observations noted that written records of an investigation of a drug complaint did not include the findings of the investigation and the follow-up.
In September, shortly after the inspection was made, Torrent Pharma revealed that it had received a Form 483 and released a statement.
“None of these observations were related to data integrity. We will respond to the US FDA within stipulated timeline and work closely with US FDA to address the observations at the earliest [sic],” said the statement.
The FDA’s findings were not the first time that the company has worked with the agency to rectify issues in its manufacturing process. In 2019, during a period when multiple companies were having issues with sartan products, Torrent Pharma was force to issue recalls on batches of losartan tablets.
At the heart of the issue was the finding of N-nitrosamine impurities across a broad range of sartan medications, which are commonly used to treat high blood pressure. At the time, Torrent Pharma recalled multiple batches of products in coordination with the FDA.