483
Novacyl RoussillonFDA 483 - Novacyl Roussillon - July 04, 2014
Record Details
Novacyl, an API manufacturer in Roussillon, France, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate investigations into out-of-specification events, lack of equipment qualification, and insufficient calibration and monitoring procedures for environmental controls. These issues indicate a failure to maintain proper quality control and documentation practices.
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ID · cf157a47-19f0-4472-8dd8-25face6cc285