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Article: Taro slapped with 24-item 483, citing cleaning validation and verification testing practices.(HUMAN DRUGS)
- Article from:
- Inspection Monitor
- Article date:
- March 1, 2006
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Taro Pharmaceutical Industries, Haifa Bay, Israel. CDER
Questionable cleaning validation and verification testing practices highlighted a 24-item 483 for Taro Pharmaceutical Industries, based in Haifa Bay, Israel. Investigators Robert Tollefsen from the Seattle District Office and Thomas Arista from CDER prepared the report.
The EIR stated that Taro is a manufacturer of active pharmaceutical ingredients (APIs) and uses multi-purpose plants on site for their production. However, many of the API plants lacked cleaning validation for the production equipment, FDA said.
For example, the SOP "Cleaning Verification/Validation in Chemical Plant" ...