This story is from May 11, 2022
USFDA
) has issued a ‘Form 483’ after inspecting its Halol facility inGujarat
. The issuance of this form implies that the US regulator found certain procedural lapses at the plant and would seek corrective action from the company.The action led to a 2.7% fall in the company’s scrip, which closed at Rs 862 on the BSE. “At the conclusion of the inspection, the USFDA issued a Form 483 with 10 observations,” the company said in a BSE filing. Exports to the US from Halol contributed 3-4% of the company’s consolidated revenues as of March 2020.Sun Pharma said the USFDA had conducted a good manufacturing practices (GMP) inspection of the Halol plant from April 26 to May 9. “The company is preparing a response to the observations, which will be submitted to the USFDA. It is committed to addressing these observations promptly and to working closely with the USFDA and continues to enhance its GMP compliance on an ongoing basis,” it added. The Halol facility has been facing troubles for a while now. The plant was last inspected by USFDA in December 2019, after which an official action indicated (OAI) was issued in March 2020. An OAI means that the USFDA expects more corrective actions to be undertaken by the company for that particular facility. Under the existing status, the company can continue with its exports of essential drugs previously approved to the US, but no new medicines can be shipped.
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