FDA 483 - IPR Pharmaceuticals, Inc. - June 14, 2018

An FDA inspection of IPR Pharmaceuticals, Inc. in Canovanas, PR, revealed a significant deficiency in control procedures for manufacturing processes. The firm failed to establish adequate controls for processes that could cause variability in in-process material and drug product characteristics. This was evidenced by temperature and humidity excursions affecting Crestor 10mg core tablets, leading to out-of-trend results for assay and degradation products, without sufficient stability data or monitoring to support product release.