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

Source: https://www.globalkeysolutions.net/records/483/steelhead-surgical-inc-boise/12014ea8-a4dd-411b-882b-7fdba0c676eb

> FDA 483 for Steelhead Surgical, Inc Boise on July 12, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Steelhead Surgical, Inc Boise
- Inspection Date: 2019-07-12
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: 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.

## Related Officers

- [Richard J. Bashay](https://www.globalkeysolutions.net/people/richard-j-bashay/ce50702d-1f5b-42c5-b50a-88bb43cba196)

Company: https://www.globalkeysolutions.net/companies/steelhead-surgical-inc-boise/d00346e0-0e25-4d4d-8dde-7a149d1f4a0c

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822