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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