FDA 483 - Summit Glove Inc - May 31, 2018

An FDA inspection of Summit Glove Inc, a specification developer in Minerva, OH, revealed significant deficiencies across its quality system. The firm failed to establish or maintain required procedures and records for purchasing, supplier management, design control, complaint handling, Medical Device Reporting (MDR), device master records, and device history records. These observations indicate a lack of fundamental controls necessary for ensuring product quality and regulatory compliance.