Indoco's Patalganga & Rabale API mfg. facilities successfully
clear US FDA inspection

Our Bureau, Mumbai

Saturday, May 19, 2018, 11:15 Hrs [IST]

Indoco Remedies Limited, a fully integrated, research-oriented Indian pharma company, announced, the successful completion of US FDA inspection at its API manufacturing facilities at Patalganga and Rabale, Navi Mumbai.

The routine FDA inspection was conducted at Patalganga facility from 7th to 11th May, 2018 and Kilo Lab facility at Rabale from 14th to 17th May, 2018.

During the audit, the FDA 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.