FDA 483 - Spring Health Products Inc - December 18, 2018

Spring Health Products Inc. in Norristown, PA, a medical device manufacturer, was inspected by the FDA from November 8 to December 18, 2018. The inspection revealed significant deficiencies across multiple quality system areas, particularly concerning design controls, complaint handling, and device record keeping for their dental curing lights. The firm failed to establish and follow adequate procedures for design changes, risk analysis, device master and history records, and complaint investigations, indicating a systemic lack of quality system compliance.