bioanalytical

FDA Inspection Summary: Topiramate ER Capsules submitted by Supernus Pharmaceuticals, Inc.

FDA did not not post any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the archives, here is the Inspection Summary for Topiramate ER Capsules submitted by Surpernus Pharmaceuticals, Inc. Inspections focused on both the clinical and analytical portions of these bioavailability studies. A FDA Form-483 was issued to the Phase I unit used for one of the studies.

Dedicated Phase I, Inc. was cited for failing to obtain a single pK sample from a subject at a single timepoint. In addition, FDA notes that the clinical study report submitted indicated that there were three pK samples drawn from separate subjects where the actual time of the pK draw was unknown. FDA goes on to note that Dedicated Phase I, Inc. closed following the FDA inspection. 

FDA Inspection Summary: Cetylev (acetylcysteine) submitted by Arbor Pharmaceuticals

FDA did not post any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the archives, here is the inspection summary for the bioanalytical portion of the Cetylev (acetylcysteine) submitted by Arbor Pharmaceuticals. The firm that conducted the bioanalytical portion of the study received a two item FDA Form 483. The citations were for:

  • Storing study samples in an unlocked freezer in an unsecured common area at the facility.
  • Computerized systems not being limited to authorized individuals, specifically that individuals from another establishment had access to electronic source records. FDA notes that the server room was accessible to individuals from a sister company in the same location.