USFDA finds lapses at Sun Pharmas Gujarat plant

Mumbai, May 11, 2022:

Sun Pharma announced on Tuesday that the US drugs regulator — US Food and Drug Administration (USFDA) has issued a ‘Form 483’ after inspecting its Halol facility in Gujarat. 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 within 15 business days. It is committed to addressing these observations promptly and remains committed 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.

The plant has been under regulatory glare since December 2015 when the warning letter to the company was issued. This was resolved after nearly three years in June 2018 after multiple USFDA inspections. However, after an inspection in the following year, USFDA issued eight observations, leading to the March development. 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. Till the issue is resolved, no fresh drug filings can be made from the plant. Times of India