INSPECTION EXPERIENCE

In an effort to keep our readers informed about agency trends, the PRCSQA publishes an "Inspection Experience" column in the chapter newsletter and website. If you have had a recent EPA or FDA inspection, please take a few minutes to print out this form and complete the following questionnaire. Any information regarding company identity will be confidential. Please FAX the completed questionnaire to Sherita Normington, Morse Laboratories, Inc., FAX (916) 481-2959.

Type of Facility: Contract Lab________Field______Sponsor/Manufacturer______
Other:________________________________________________________
Regulatory Agency: EPA______FDA______
Other:_________________________________________________________
Inspection Type: GLP______GCP______GMP______
# of Days Notice Given:______ # of Inspectors:______ Length of Inspection:__________
# of Studies Inspected:______

Status of Studies: Active______Completed______

Type of Inspection: Data______Facility______Validation of automated systems______
Other:________________________________________________________________
Directed______Routine______
Other:________________________________________________________________
Please list three areas of inspection focus
1._____________________________________________________________________________________
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2._____________________________________________________________________________________
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3._____________________________________________________________________________________
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Please include three "tips" for people who are going to be inspected
1._____________________________________________________________________________________
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2._____________________________________________________________________________________
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3._____________________________________________________________________________________
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Any additional information you can provide is appreciated.

Thank you, PRCSQA