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Article: FDA objects to company's revised Process Validation Protocol.(Medical Devices)
- Article from:
- Validation Times
- Article date:
- December 1, 2003
CopyrightCOPYRIGHT 2003 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 Sept. 16-30 inspection revealed that contact lens solution maker Applied Labs, Columbus, IN, was operating in violation of Quality System regulations and process validation for equipment, operations and installations qualifications--all resulting in the receipt of a 483 and warning letter.
FDA stated that it issued the Nov. 19 letter because Applied's Oct. 20 response to the inspection was inadequate. The warning letter stated that although Applied provided revised procedures for production and process change controls, none of the 10 items listed as changed referred to the frequency of QC checks.
For example, the manufacturer submitted a new Process ...