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

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.