FDA issues form 483 with 9 observations to Natco's Kothur unit

Natco Pharma Limited Thursday said the US Food and Drug Administration has issued nine observations under Form 483 for its formulation facility in Kothur Village, near here. According to a press release from the city-based drug-maker, the inspection was conducted between May 30 and June 5 and the company would provide due justifications and corrective action plan within the next 15 working days to address the USFDA observations.

At the end of the inspection, the facility received nine observations, with no repeat observations and mostly procedural in nature. The company believes that none of the observations was related to data integrity and that all of the observations can be addressed within a short period of time, the release said.

Visual inspection of products carried out as part of the investigation was not properly documented, the FDA said in one of the observations. As per the USFDA, Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that in its judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

Natco shares closed at Rs 535.30 a piece down 2. 13 per cent over the previous close on BSE.