483
ARC Medical Inc.ARC Medical Inc. – FDA 483, Nov 14, 2019
Record Details
An FDA inspection of ARC Medical Inc., a medical device repackager/relabeler in Tucker, GA, identified two significant observations. The firm failed to adequately establish procedures for ensuring purchased products and services conform to specified requirements, including defining supplier controls. Additionally, the company did not adequately establish or implement training procedures, with no documented employee training for new quality policies and procedures.
- Office
- Atlanta District Office
- Person
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ID · a259495d-48e0-4ed4-9210-dc6b02b4802f
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