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Article: AvTech Laboratories nets clean audit: AvTech Laboratories, Portage, MI, Detroit, MI, District.(HUMAN DRUGS)
- Article from:
- Inspection Monitor
- Article date:
- April 1, 2008
CopyrightCOPYRIGHT 2008 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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AvTech Laboratories, Portage, MI, a contract laboratory specializing in pharmaceutical products, bioanalytics, method development, and quantitative microbiology testing, received a clean inspection following a recent pre-approval GMP audit.
FDA investigator Azza Talaat from the Detroit, MI, District Office conducted the inspection. The following verbal observations were noted at the close of the audit:
* Suitability of use study on the filter used in sample preparation for HPLC chromatographic printouts did not include when a chromatogram is the result of reprocessing; and
* The SOP for laboratory investigation reporting did not address in ...
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