The FDA’s findings were not the first time that the company has worked with the agency to rectify issues in its manufacturing process.
We will respond to the US FDA within stipulated timeline and work closely with US FDA to address the observations at the earliest ,” said the statement. “None of these observations were related to data integrity. In September, shortly after the inspection was made, Torrent Pharma revealed that it had received a Form 483 and released a statement. 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. 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 inspector continued to note that the analytical cleaning method used to monitor the effectiveness of the manual cleaning process was inadequate. The agency provided an example where white powder residue was observed on different surfaces of a manufacturing suite that had been marked as cleaned. More specifically, the Form 483 outlines, “Your manual cleaning procedure for non-dedicated manufacturing equipment is inadequate in that does not ensure the removal of residues from the previously manufactured product to avoid cross-contamination”.
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. The inspection took place between September 9-28 and was conducted in Indrad, Gujarat, at a finished product and active pharmaceutical ingredient (API) plant.Īccording 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.
Tabletting, coating & ancillary equipment.Excipients, raw materials and intermediates.APIs (active pharmaceutical ingredients).
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