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Poor Investigations Doom API Maker to Form 483

November 7, 2014

An active pharmaceutical ingredient maker was chided by the FDA for not investigating the root cause of poor quality results.

The FDA slapped Novacyl with a Form 483 after a July inspection of its Roussillon, France, facility. The agency determined that in 2013 the API maker failed to have any recommendations to address out-of-specification results for certain APIs and failed to determine the root cause of the failures.

In addition, the company did not have a written procedure to describe the requirements for an investigation when deviations occur during different steps of the production process, reads the July 4 form with four observations.

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