Cadila's U.S. facility in St. Louis cited by FDA for 11 observations: report

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Cadila's U.S. manufacturing facility was cited by the FDA for 11 observations on the heels of 14 citations last month for one of its India plants. (Cadila)

Cadila Healthcare’s U.S. drug manufacturing facility in St. Louis was cited by the FDA for observations in the wake of the company’s Moraiya, India, plant getting tagged by the regulatory agency for a dozen observations last month.

In a Bombay Stock Exchange filing cited by the Business Standard, the company said the inspection of its Nesher Pharmaceuticals sites by the FDA between May 13 and May 31 resulted in a total of 11 observations.

Nesher is a wholly owned subsidiary of Cadila.

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“The inspection concluded with 3 observations at one (Nesher) facility and 8 observations at the other” the company said in the filing. The agency issued the observations with a recommendation for Voluntary Action Indicated, the company said.

Cadila said the inspections were product-specific and pre-approval with general current good manufacturing practice, and there were no observations related to data integrity, the Standard reported.

RELATED: Cadila Moraiya plant hit with 14 observations, but no repeats, it says

In early May, Cadila reported a two-week FDA inspection of its Moraiya formulation facility received 14 observations but that it was “confident” it would be able to fix them.

The largest facility in India that makes drugs for the U.S. market, the Moraiya plant was one of two that were hit with a warning letter in late 2015 for a number of issues. Problems have also been found at other Cadila manufacturing sites, including a sterile injectables plant in Vadodara, India.

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