FDA Clinical Inspection Summary: Mesalamine delayed release capsules submitted by Warner Chilcott

FDA did not post any warning letters addressed to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the archives, here is the clinical inspection summary for the bioavailability study for mesalamine delayed release capsules submitted by Warner Chilcott. The clinical site received a FDA Form 483 for the following:

  • Failing to follow the investigational plan, specifically with regards to failing to document the times associated with required sample processing steps for PK samples. FDA excluded six of these samples from analysis, as sample stability could not be supported. 

The bioanalytical portion of this study was inspected, and the bioanalytical site received a FDA Form 483 for the following:

  • Failing to conduct an experiment to determine the effect of hemolysis on analyte measurement and failing to document the number of hemolyzed samples received.
  • Failing to confirm specificity during validation
  • Failing to apply changed parameters to all samples in a chromatographic run
  • Stating in a report that frozen stability of samples was proven to be 287 days in at -80 degrees C, but failing to provide the supporting data.
  • Failing to perform required calibration and maintenance on all instruments in the lab.