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Article: Lack of 'diligence' earns Atlanta firm a warning.(Perfecto Products Manufacturing)(Brief Article)
- Article from:
- Validation Times
- Article date:
- December 1, 2001
CopyrightCOPYRIGHT 2001 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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Perfecto Products Manufacturing of Atlanta, GA, took hits for stability and active ingredient assays in the November-December 2000 audit by investigator Leah Andrews of the Atlanta district. The outcome of the one-page 483 was a March 29, 2001, warning letter (Doc. 10331W) in which Atlanta district director Ballard Graham slammed the firm for failing to exhibit "diligence in bringing your firm into compliance." Graham's ire was predicated by the fact that several of the findings were also noted in a 1996 inspection.
The firm's vice president, Marvin Hirsh, responded twice to the 483, but the warning letter reiterated the inspection findings, including that ...