IPCA Labs Slides 2% On Account Of API Unit Inspection By USFDA
On Wednesday, the stock price of IPCA laboratories was down by 2.17 per cent to Rs 718.90 as of 10:52 IST on account of an inspection done by USFDA on an API manufacturing unit of the company in Madhya Pradesh.
IPCA in an exchange filing revealed that its API (Active Pharmaceutical Ingredients) facility situated at Ratlam, Madhya Pradesh was inspected US FDA between the 5th of June to the 13th of June, 2023.
Upon inspection, USFDA issued a Form 483 with 11 observations to the company's API facility. According to USFDA, an FDA Form 483 is issued to a firm's management at the conclusion of an inspection when an investigator observes any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
"This is to inform you that the US FDA conducted the inspection of the Company’s APIs manufacturing facility situated at Ratlam, Madhya Pradesh from 5th June 2023 to 13th June 2023. At the conclusion of the inspection, the US FDA issued Form 483 with 11 (eleven) observations," the company said in the filing.
IPCA stated that it will submit its comprehensive response to these observations to the US FDA within the stipulated time and will work closely with the agency to resolve these issues at the earliest.
"The company takes the quality and compliance issues with utmost importance and remains committed to maintaining the highest standards of quality and compliance across all its manufacturing facilities," the company said in a statement post-conclusion of the inspection.
