Manufacturing facilities at Patalganga and Rabale were inspected successfully
Indoco Remedies 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 May 7 to 11, 2018 and Kilo Lab facility at Rabale from May 14 to 17 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 three observations; none of them are critical or pertain to data integrity.