FDA Inspection 1224418 — HealthTech Wound Care, Inc.
The FDA completed an inspection of HealthTech Wound Care, Inc. on Dec 8, 2023 in Salt Lake City, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 13 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 8, 2023
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Salt Lake City, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12321 | 21 CFR 1271.160(b)(3) | Problem description, disposition, date et. al. |
| 12345 | 21 CFR 1271.190(b)(1) | Clean, sanitary, orderly manner |
| 12354 | 21 CFR 1271.190(d)(2) | Documentation of activities |
| 12356 | 21 CFR 1271.195(a) | Adequate control, proper conditions |
| 12357 | 21 CFR 1271.195(a)(1) | Temperature and humidity controls |
| 12367 | 21 CFR 1271.200(a) | Design appropriate, suitably located |
| 12375 | 21 CFR 1271.210(a) | Use prior to verification |
| 12387 | 21 CFR 1271.220(a) | Causing contamination, increasing risks |
| 12395 | 21 CFR 1271.225 | Verification/validation |
| 12399 | 21 CFR 1271.230(a) | Process validation procedures |
| 12435 | 21 CFR 1271.270(a) | Records maintained concurrently |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |