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Article: Quality systems deficient at Swiss American Products.(Medical Devices)
- Article from:
- Validation Times
- Article date:
- November 1, 2008
- Author:
CopyrightCOPYRIGHT 2008 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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Swiss American Products was in violation of GMPs, according to Aug. 12-15, Aug. 19 and 27 and Sept. 4 inspections of its Carrollton, TX, facility. The firm, which manufactures and distributes wound care products, was cited for procedural and validation failures, specifically for Elta Hydrovase Gel, Elta Silver Antimicrobial Wound Gel, Elta Wound Gel, Elta Wound Cleanser, Elta Impregnated Gauze and Elta Soft Gauze products.
The firm verbally annotated on the FDA 483 "promised to correct" for 13 of the 15 inspectional observations and "corrected and not verified" for two remaining inspectional observations. On Sept. 16, Chief Operating Officer Ede Payne ...