Zydus Cadila and Lupin Cited for Mfg Issues by FDA

By Emily Forster -

June 5, 2019

Zydus Cadila, an Ahmedabad, India-based pharmaceutical company, reports that the US Food and Drug Administration (FDA) has issued 11 observations following an inspection of the company’s manufacturing facilities in St. Louis, Missouri. The facilities are part of Nesher Pharmaceuticals, a subsidiary of Zydus’ US pharmaceutical arm, Zydus Pharmaceuticals USA.

In a Bombay Stock Exchange (BSE) filing, the company stated inspections of the St. Louis facilities of Nesher Pharmaceuticals resulted in a total of 11 observations, three at one facility and eight at another facility. The FDA issued the observations with a recommendation for “Voluntary Action Indicated,” which means objectionable conditions or practices were found, but the FDA is not taking or recommending any administrative or regulatory action.

The company said that the inspection was a product specific pre-approval inspection with general cGMP, and that there were no data-integrity-related observations.

The company said in the BSE filing that it is “confident of addressing these observations” and responding to the FDA.

In a separate development, Lupin Ltd., a pharmaceuticals manufacturer based in Mumbai, reports that it may be subject to regulatory action by the FDA for one of its plants in Goa, India. Lupin reported in a BSE filing that it had received a notice from the FDA, classifying an inspection conducted by the FDA at the Goa facility between January 28 and February 8, 2019, as “Official Action Indicated” (OIA). OAI classifications mean regulatory and/or administration actions will be recommended. The inspection of the Goa facility resulted in two observations.

The company reports that the FDA may withhold approval of any of Lupin’s pending applications or supplements. Lupin says that based on the FDA’s Concept of Operations program, the company understands that the status of the facility is still under review and says it does not believe that this inspection classification will have an impact on supplies or existing revenues from operations of the Goa facility.

The company says it is in the process of sending further updates of its corrective actions to the FDA.

Source: Zydus Cadila, Lupin, and FDA