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Article: Cardinal subsidiary popped on 483, evades warning. (Human drugs).
- Article from:
- Validation Times
- Article date:
- March 1, 2002
CopyrightCOPYRIGHT 2002 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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Chicago district investigators Alicia Mozzachio and Mark Jiminez came across problems with media fills and validation lapses during their March 2001 inspection of contract drug maker Automatic Liquid Packaging (ALP) of Woodstock, IL, but the wholly-owned subsidiary of Cardinal Health of Dublin, OH, nonetheless managed to slip out of the noose without a warning letter.
Cardinal bought ALP in 1999 and, according to the EIR, steered the operation through a pre-approval audit the following year. Despite that earlier success, the 2001 inspection generated 11 deviations listed on the 483, which, like the EIR, was heavily redacted.
The 483 cited ALP for a ...