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FDA's GLP Inspection of PBL Had No Observations

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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