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News | October 31, 2017

FDA’s GLP Inspection of PBL Had No Observations

by PBL

Between October 25th and 27th, the FDA inspected Pacific BioLabs for GLP compliance.  The FDA inspector looked at the following systems or items:

  1. Vendor list and approval process
  2. Internal audits
  3. IACUC membership
  4. Qualification of feed
  5. Deviations
  6. CAPAs
  7. Cleanroom access
  8. Training documents
  9. SOPs
  10. Calibration reports
  11. Master study schedule
  12. Change control
  13. Archiving of GLP studies
  14. GLP supplies
  15. Service agreements with suppliers
  16. GLP study packets
  17. Temperature mapping of rooms
  18. Temperature readings for chambers

There were no observations and no 483 written.  All Pacific BioLabs’ procedures and systems were found to be in compliance with GLP regulations.  PBL prides itself on providing excellent service to clients and one aspect of good service is providing high quality testing that stands up to regulatory scrutiny.

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