electronic records

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. 

Clinical Inspection Summary: Otezla (apremilast) by Celgene

FDA did not issue any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the archives, here is the clinical inspection summary for Otezla (apremilast) by Celgene. Three sites were selected due to high enrollment, relatively high percentage of treatment responders and randomization irregularities. Site inspections lasted ranged from four to eight days. One site received an FDA form 483.

Dr. Wasel was cited for failing to reconsent subjects to an updated informed consent form at their next visit. FDA also noted that only one study coordinator had access to an electronic system called Sitepad and Studyworks for recording  investigator assessments, and appears to note that the investigator should have had access to this electronic data as well.