FDA Inspection 1264944 — Immunotec Research Incorporated
The FDA completed an inspection of Immunotec Research Incorporated on Mar 26, 2025 in The Woodlands, TX. 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). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 26, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- The Woodlands, TX (United States)
Additional details
FSVP
Citations
| ID | CFR | Description |
|---|---|---|
| 18366 | 21 CFR 1.511(c)(1) | No CGMPs - supplier approval, performance, risk |
| 18383 | 21 CFR 1.511(c)(1) | No CGMPs - record, English |
| 18388 | 21 CFR 1.511(c)(2)(i) | No CGMPs - approval procedures |
| 18549 | 21 CFR 1.511(c)(5)(i)(A)(4) | No CGMPs - record onsite audit |
| 18550 | 21 CFR 1.511(c)(5)(i)(B) | No CGMPs - sampling, testing |