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.