DNA GENOTEK, INC. FDA Inspection Record
DNA GENOTEK, INC. is an FDA-registered facility (FEI 3003742580) located in Ottawa Ontario, CA. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Nov 3, 2016: Voluntary Action Indicated (VAI)
- Inspections on record
- 2 (1 OAI, 1 VAI)
- Last OAI inspection
- Sep 20, 2013
- Warning letters
- 1 listed by FDA for this FEI, latest Dec 20, 2013
- Recalls as the recalling firm
- 2, latest Feb 18, 2022
- Import refusals
- 2
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Nov 3, 2016 | Voluntary Action Indicated (VAI) | No citations listed |
| Sep 20, 2013 | Official Action Indicated (OAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Feb 18, 2022 | Class II | Z-0981-2022 | ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers:
OCD-100… and 1 more product Evaporation of stabilizing liquid reducing shelf life. |
| Jun 24, 2020 | Class III | Z-3004-2020 | PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST… Reagents were shipped to customers after the Use by data indicated on its labeling. |
Facility details
- Company
- DNA Genotek Inc.
- Location
- Ottawa Ontario (CA)
- Source
- device