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Article: FDA checks DePuy MDRs, recalls, complaints, GMPs, sterilization by irradiation.(United States Food and Drug Administration)(Brief Article)
- Article from:
- Inspection Monitor
- Article date:
- April 1, 1996
CopyrightCOPYRIGHT 1996 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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DePuy, Warsaw, IN, Detroit District.
FDA inspected DePuy on four occasions in 1993 and three more in 1995, but avoided a 483 in both cases. The company had a respite from inspections during 1994, although it received a warning letter that year in which the agency cited instances of overstepping the bounds of 510(k)s.
A January 1993 inspection by Investigator William Brubaker -- who conducted the later inspections as well -- probed the recall of three lots of Apex Hole Eliminators, metal plugs to be screwed into acetabular cup shells. The recall resulted from complaints that plug threads did not match the threads in the shells. The EIR noted that DePuy ...