Inova Lasers LLC — FDA Facility Profile
Inova Lasers LLC is an FDA-inspected facility (FEI 3015191149) located in New York, NY, US. RegDataLab tracks 2 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Sep 17, 2021: Voluntary Action Indicated (VAI)
- Inspections on record
- 2 (1 OAI, 1 VAI)
- Last OAI inspection
- Feb 7, 2020
- 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 Jan 29, 2020
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Sep 17, 2021 | Voluntary Action Indicated (VAI) | Legible reproductions (21 CFR 1040.10(h)(1)(iii)) Aperture label (21 CFR 1040.11(a)(3)) Certification other than by tag or label (21 CFR 1010.2(b)) |
| Feb 7, 2020 | Official Action Indicated (OAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Incoming acceptance records, documentation (21 CFR 820.80(b)) Purchasing controls, Lack of or inadequate procedures (21 CFR 820.50) Certification label or tag (21 CFR 1010.2(b)) and 7 more |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jan 29, 2020 | Not yet classified | Z-0440-2021 | Class IV New Era medical laser device The firm failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with… |
Facility details
- Company
- Inova Lasers LLC
- Location
- New York, NY (US)
- Source
- inspections