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IVF Michigan P.C., Rochester Hills, MI, Sept. 21 (Detroit).

Publication: Warning Letter Bulletin
Publication Date: 01-OCT-06
Format: Online
Delivery: Immediate Online Access
Full Article Title: IVF Michigan P.C., Rochester Hills, MI, Sept. 21 (Detroit).(BLOOD & BIOLOGICS)

Article Excerpt
During a June 20-July 10 FDA investigation, serious deviations from the regulations for human cells, tissues, and cellular and tissue-based products were documented.

Violations included, but were not limited to, failure to test specimens from anonymous donors of cells or tissues for evidence of infection due to relevant communicable...

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