Quality And Regulatory Update

Pacific BioLabs’ last FDA inspection was in March of 2007 for a directed GLP inspection in support of a client PMA.  No Inspection findings were reported in a Form 483.  During the exit meeting, the inspector provided the following verbal accolades:

• Deviations from protocol were documented completely and understandably. 
• There was complete congruency between the raw data and the reports.  There was good data integrity –the collection of raw data was complete and thorough.

An EPA GLP Inspection was performed in August of 2007 to review FIFRA testing in support of a client submittal.  This inspection was also performed to OECD requirements by an accompanying foreign national who was observing US EPA practices.  Five minor findings were reported by the inspector dealing with regulatory interpretations.  Data integrity was thoroughly reviewed and accepted without identification of deficiency. 

USDA inspection in September of 2007 resulted in no findings.

back to main news page