483
Viking Rubber Products Inc.FDA 483 - Viking Rubber Products Inc. - April 29, 2019
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Record Details
An FDA inspection of Viking Rubber Products Inc., a medical device manufacturer in San Clemente, CA, identified three significant observations. The firm was cited for deficiencies in device history records not aligning with device master records, a lack of documented process validation activities for manufacturing, and inadequate procedures for finished device acceptance, including issues with inspection records and quantity tracking.
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ID · 15c5b3b6-9985-4690-a681-5365d50540f1