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Article: Unvalidated rework procedure one cause of metal shavings in tablets: FDA.(Brief Article)
- Article from:
- Validation Times
- Article date:
- May 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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A failure to validate rework procedures to yield product "meeting predetermined specifications" was one of the factors contributing to the presence of metal shavings in tablets manufactured by Berlex Laboratories, FDA said in a March 11 warning letter.
A Jan. 3-Feb. 4 inspection of the firm's Wayne, NJ, drug manufacturing facility by an unnamed investigator found other significant GMP violations involving its Quinaglute Dura-Tabs (quinidine gluconate extended release tablets, USP).
The letter addressed to Berlex President Robert Chabora stated Berlex failed to prevent the release of six lots of the product that "contained visible metal fragments which ...