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ACS Dobfar, Milan, Italy, July 21, Rockville, MD (CDER).

Publication: Warning Letter Bulletin
Publication Date: 01-AUG-05
Format: Online
Delivery: Immediate Online Access
Full Article Title: ACS Dobfar, Milan, Italy, July 21, Rockville, MD (CDER).(HUMAN DRUGS & DIETARY SUPPLEMENTS)

Article Excerpt
Several GMP deficiencies were discovered during an FDA inspection conducted March 14-24 of ACS Dobfar's Milan sterile manufacturing facility. The July 21 warning letter noted that similar deficiencies were uncovered during an earlier May 2002 inspection, which included laboratory controls, environmental monitoring and validation of sterilization processes among other...

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