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Resolved all issues leading to USFDA import alert on Vizag unit: Divis Labs

6 observations were made after the USFDA completed its audit on Sept 19

BS Reporter  |  Hyderabad 

Pharmaceuticals, drugs, pharma industry, medical, health, lab
Illustration: Binay Sinha

The Hyderabad-based Limited on Wednesday said that its Unit-2 plant in Visakhapatnam, which has been under import alert for the past six months, has resolved all issues related to the observations made by the US Food and Drug Administration (USFDA) in its latest CGMP audit. The successful implementation of the post-audit corrective plan is expected to pave the way for the lifting of the import alert, which was issued as the US drug regulator pointed some manufacturing-related issues in the said plant. Responding to the news, the company scrip rose by 8.13 per cent to Rs 934 during afternoon trade on the Bombay Stock Exchange (BSE). While clearing the plant level issues related to the previous set of observations, the USFDA team has issued a Form 483 with a set of 6 fresh observation, following an audit that took place between September 11 and September 19. Without giving any specific details, Divis Lab's management stated that the new set of observations were procedural in nature and will be addressed within the stipulated period. In March, the US drug regulator issued an import alert against the firm's Unit-2 plant.

The firm was subsequently charged on two counts, one involving manufacturing compliance issues and the other for denying access to carry out an inspection of the plant, despite a warning being issued to the firm's management in this regard. However, the drug regulator had exempted a majority of the active pharmaceutical ingredient (API) products that are being manufactured at the site from the import ban, citing a potential drug scarcity back in US. The import alert issued over denial of site access has been already lifted by the USFDA. An import alert or a warning letter from the US drug regulator has serious implications for a defaulting company, as the import of products in US stand disallowed until the issues raised by the inspectors are resolved. In case of Divis Labs, the drug regulator exempted most of the products from import ban and also facilitated the company to come out of the import alert in a matter of six months unlike in other cases.

First Published: Wed, September 20 2017. 16:37 IST