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1.
Spectrophometers Need Attention Too
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(Pharmaceuticals)
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October 12, 2010
WARNING LETTER
CIN-11-108087-01
Via United Parcel Service
Gregory A. Neal President and Owner Advanced Testing Laboratory, Inc. 6954 Cornell Road, Suite 200 Cincinnati, Ohio 45242 ...
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Created on 12 October 2010
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2.
Prevent the growth of undesirable microorganisms
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(Food)
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... home page at www.fda.gov.
During the inspection, the FDA investigators discussed with you observations noted on the Form FDA-483, Inspectional Observations, which was issued to you on May 5, 2009. ...
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Created on 10 October 2010
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3.
TrackPro Home Page
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(General)
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TrackPro is a software solution that allows you to track and manage the status of recurrent activities such as calibrations, maintenance, and reminders. Tracking and controlling these activities will assist ...
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Created on 16 September 2010
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4.
Calibration of Process Monitoring Equipment
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(Pharmaceuticals)
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... HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
1. You must implement ...
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Created on 16 August 2010
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I want to thank you for the very generous donation of your TrackPro client/server Calibration Tracking Software to Stevens SPRC. We very much appreciate your willingness to support our research and educational efforts.
As we discussed TrackPro will only be used in our Pharmaceutical research program (SPRC) and as part of our course "Contemporary Concepts in Pharmaceutical Validation."
I have copied my Program Director, Dr. Richard Berkof and my Department Chairmen and Deputy Dean Dr. Constantin Chassapis on this email to make them aware of your generous gift.
It was a great pleasure talking with you last week, especially a ex-J&J colleague. Many thanks once again!
Best regards,
Andrew Walsh
Industry Professor Pharmaceutical Manufacturing and Engineering Program
Stevens Institute of Technology