# FDA 483 - HealthTech Wound Care, Inc. - December 08, 2023

Source: https://www.keypedia.com/records/483/healthtech-wound-care-inc/4facb0c0-8232-490d-b2c9-020848cb8738

> FDA 483 for HealthTech Wound Care, Inc. on December 08, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: HealthTech Wound Care, Inc.
- Inspection Date: 2023-12-08
- Product Type: biologics
- Office Name: Denver District Office
- Summary: An FDA inspection of HealthTech Wound Care, Inc. revealed significant deficiencies in the manufacturing of AmnioBind/DermaBind TL products, including failures in process validation, equipment design and maintenance, and environmental controls. The firm also lacked adequate record-keeping, used unverified supplies, and failed to properly screen HCT/P donors, indicating a high risk to product quality and patient safety. These issues collectively demonstrate a systemic lack of control over critical manufacturing processes and quality systems.

## Related Officers

- [Creighton T. Tuzon](https://www.keypedia.com/people/creighton-t-tuzon/be0d09c0-59f4-48c3-9e3d-a1ceb2587e3e)
- [Emily B. Camire](https://www.keypedia.com/people/emily-b-camire/dff5f4c6-bcbe-4ef1-ac0b-1b2701b311ef)

Company: https://www.keypedia.com/companies/healthtech-wound-care-inc/d8fab668-e7ba-4df0-a045-fef63806df66

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face