FDA 483 - Health Science Products Inc - August 23, 2019

An FDA inspection of Health Science Products Inc, a medical device manufacturer in Hueytown, AL, revealed numerous significant deficiencies in its quality system. The firm failed to establish and implement essential procedures for medical device reporting, corrective and preventive actions, and complaint handling. Additionally, the inspection found a lack of proper maintenance for device master records, device history records, purchasing controls, quality audits, and management reviews, indicating a broad failure to comply with quality system requirements.