FDA Inspection

HealthTech Wound Care, Inc.December 8, 2023

HealthTech Wound Care, Inc. – FDA Inspection, Dec 8, 2023

Record Details

This FDA Inspection record concerns HealthTech Wound Care, Inc., with an inspection on December 8, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company: HealthTech Wound Care, Inc.
Inspection Date: December 8, 2023
Product Type: Biologics
Office: Center for Biologics Evaluation and Research
People: Creighton T. Tuzon (Issuing Officer)
Emily B. Camire (Issuing Officer)

View Company Profile

ID · cbb5caac-30c5-4b6a-af1d-6907a2089f55

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1224418
FDA center: Biologics
Project area: Human Cellular, Tissue, and Gene Therapies
Outcome: Form 483 issued

FDA Citations

21 CFR 1271.160(b)(3)Problem description, disposition, date et. al.
21 CFR 1271.190(d)(2)Documentation of activities
21 CFR 1271.195(a)Adequate control, proper conditions
21 CFR 1271.195(a)(1)Temperature and humidity controls
21 CFR 1271.200(a)Design appropriate, suitably located
21 CFR 1271.190(b)(1)Clean, sanitary, orderly manner
21 CFR 1271.50(a)Determination based on screening and testing
21 CFR 1271.220(a)Causing contamination, increasing risks
21 CFR 1271.230(a)Process validation procedures
21 CFR 1271.225Verification/validation

Showing 10 of 25 citations.

Full citation text and observation details available on the Dashboard.

Discuss this record with AI

KeyPedia

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore HealthTech Wound Care, Inc.