The FDA found that not only didn’t the company follow its responsibilities and procedures applicable to the quality control unit, the company’s laboratory controls also “do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.”
The inspectors also found that the site -- which is home to Catalent's inhalation franchise including product development, clinical and commercial manufacturing – failed to thoroughly review unexplained discrepancies of whether or not batches had already been distributed.
In addition, written production and process control procedures were found to be “not followed in the execution of production and process control functions.” Deviations from written production and process control procedures were also not justified, according to the inspectors.
More specifically, FDA inspectors noted that during the review of multiple deviation reports, “it was observed that stability testing was performed outside the stability testing date range as prescribed,” and Catalant also “failed to mention a non-proceduralized practice that tracks stability sample due dates using an informal Excel spreadsheet as a potential root cause of the deviations.”
Catalent spokesman Chris Halling told us: "I can confirm that on March 20, 2015, following a routine inspection of Catalent’s Morrisville, NC facility, the US FDA made six 483 observations. Catalent responded by immediately effecting measures to resolve the observations. The FDA later recommended approval of the Morrisville facility for the manufacturing and testing of the products concerned."