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USFDA completes inspection of Indoco's API manufacturing facilities

18 May 2018 Evaluate

The United States Food and Drug Administration (USFDA) has successfully completed inspection of Indoco Remedies’ API manufacturing facilities at Patalganga and Rabale, Navi Mumbai. The routine USFDA inspection was conducted at Patalganga facility from May 7-11, 2018 and Kilo Lab facility at Rabale from May 14-17, 2018.

During the audit, the USFDA thoroughly inspected Indoco’s entire quality management systems to ensure compliance with federal regulations. The inspection included a review of production facility, processes and procedures, training records, quality systems and control procedures.

The Kilo Lab facility received zero 483s from the agency, while its API plant at Patalganga cleared the inspection with 3 observations; none of them are critical or pertain to data integrity.

Indoco Remedies is engaged in the manufacturing and marketing of formulations (finished dosage forms) and active pharmaceutical ingredients (APIs) in India.


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