FDA 483 - Catalent Pharma Solutions LLC - May 19, 2017

The FDA issued a Form 483 to Catalent Pharma Solutions LLC following an inspection of their Morrisville, NC Control Testing Laboratory from May 15-19, 2017. The inspection revealed two significant observations concerning their quality systems and facility controls.

Firstly, the company's quality control unit did not consistently adhere to its established procedures. Specifically, several customer complaint investigations and non-conformance reports, including Out-of-Specification (OOS) investigations for materials like Albuterol Sulfate API and Polyethylene Glycol, were not completed within their defined due dates. Furthermore, extensions for these overdue investigations were not submitted or approved as required by company Standard Operating Procedures. There was also a delay in initiating a customer complaint beyond the specified three-business-day requirement.

Secondly, the inspection noted deficiencies in maintaining separate or defined areas to prevent contamination and mix-ups, particularly regarding the storage of drug products after release. An example cited was the disorganized storage of equipment, product containers, and stability samples for Albuterol Sulfate and Levalbuterol Tartrate HFA in a "shell area," for which the company could not provide an inventory or final disposition. These observations indicate a need for Catalent Pharma Solutions LLC to enhance their adherence to internal quality procedures and improve facility organization to ensure compliance with regulatory expectations. The company is expected to implement corrective actions to address these findings.