Spartronics Watertown LLCOctober 28, 2021

FDA 483 - Spartronics Watertown LLC - October 28, 2021

Record Details

An FDA inspection of Spartronics Watertown LLC in Watertown, SD, a medical device manufacturer, revealed a significant issue with their quality system. The firm failed to adequately establish and implement procedures for controlling nonconforming product. This indicates a moderate severity finding related to quality system deficiencies.

Company: Spartronics Watertown LLC
Inspection Date: October 28, 2021
Product Type: Device
Office: Minneapolis District Office
Person: Christina L. Bigham (Investigator )

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