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The USFDA has completed the inspection of Indoco Remedies, API manufacturing facilities at Patalganga and Rabale, Navi Mumbai.
In a release the company stated that, the inspection was routine and was conducted at Patalganga facility from May 7 to 11, 2018 and Kilo Lab facility at Rabale from 14 to 17, 2018.
During the audit, Indoco’s entire quality management systems was inspected,to ensure compliance with federal regulations. The inspection included a review of production facility, processes and procedures, training records, quality systems and control procedures.
Further, the Kilo Lab facility received zero 483 observations from the agency, while its API plant at Patalganga cleared the inspection with 3 observations, but none of them are critical or pertain to data integrity.
