483
Robling Medical IncFDA 483 - Robling Medical Inc - November 26, 2019
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Record Details
Robling Medical Inc, a contract manufacturer in Youngsville, NC, was cited for five observations during an FDA inspection. The inspection revealed significant deficiencies in environmental control procedures, corrective and preventive action documentation, statistical techniques for product acceptability, rework documentation, and complaint file maintenance. These issues indicate a lack of adherence to quality system requirements.
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ID · 493e15c8-6540-4cb0-9fdc-f412e7998627