FDA Inspection
Immunotec Research IncorporatedFDA Inspection 1264944 - Immunotec Research Incorporated - March 26, 2025
Record Details
This FDA Inspection record concerns Immunotec Research Incorporated, with an inspection on March 26, 2025, issued by the Dallas District Office, covering foods & cosmetics.
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ID · a36a405a-a191-464f-971b-c19a8c996eec
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1264944
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 1.511(c)(1)No CGMPs - supplier approval, performance, risk
- 21 CFR 1.511(c)(2)(i)No CGMPs - approval procedures
- 21 CFR 1.511(c)(1)No CGMPs - record, English
- 21 CFR 1.511(c)(5)(i)(A)(4)No CGMPs - record onsite audit
- 21 CFR 1.511(c)(5)(i)(B)No CGMPs - sampling, testing
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Other FDA inspections of Immunotec Research Incorporated
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 21, 2024 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
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