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American Health Foundation, Valhalla, NY, New York District
American Health Foundation (AHF), Valhalla, NY, failed to correct numerous deficiencies discovered in a 1997 inspection despite the fact that a warning letter was issued and the company, in its response to FDA, said the issues would be corrected.
This follow-up inspection, conducted by FDA investigators Thomas Hansen and L. Glenn Massimilla of the New York District in July 2001, also discovered that the company was not, at the time, conducting FDA-related GLP studies, but it wanted to keep the option open for studies in the future. AHF handled mostly animal studies related to cancer research, according to FDA documents.
The initial January 1997 audit found the facility had not validated its computer system used for detecting Unscheduled DNA Synthesis Assay (UDS), according to FDA inspection records.
According to the EIR: "It was also noted that the computer generated …