FDA 483 - Steelhead Surgical, Inc Boise - July 12, 2019

An FDA inspection of Steelhead Surgical, Inc Boise, an HCT/P distributor in Boise, ID, revealed significant deficiencies in their quality system. The firm failed to establish and implement written procedures for critical operations such as tissue receipt, storage, packaging, distribution, complaint handling, and returned product suitability. Additionally, the inspection found that storage temperatures for human tissue products were not adequately recorded or monitored.