PROLLENIUM MEDICAL TECHNOLOGIES INC. FDA Inspection Record
PROLLENIUM MEDICAL TECHNOLOGIES INC. is an FDA-registered facility (FEI 3004423487) located in Aurora Ontario, CA. RegDataLab tracks 2 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Nov 1, 2018: Voluntary Action Indicated (VAI)
- Inspections on record
- 2 (1 VAI, 1 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 1, latest Nov 15, 2018
- Import refusals
- 10 or more
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Nov 1, 2018 | Voluntary Action Indicated (VAI) | Procedures not adequately established or maintained (21 CFR 820.40) Lack of or inadequate procedures (21 CFR 820.100(a)) |
| Apr 20, 2017 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Nov 15, 2018 | Class II | Z-1146-2020 | Revanesse Versa, PN40081 Labeling error. The product is labeled with an 18 month expiration date, however the product is approved for 12 months. |
Facility details
- Company
- Prollenium Medical Technologies Inc.
- Location
- Aurora Ontario (CA)
- Source
- device