COSMEDENT, INC. FDA Inspection Record
COSMEDENT, INC. is an FDA-registered facility (FEI 1450653) located in CHICAGO, IL, US. RegDataLab tracks 5 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- Jun 7, 2017: No Action Indicated (NAI)
- Inspections on record
- 5 (2 VAI, 3 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
- 2, latest Jul 20, 2023
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jun 7, 2017 | No Action Indicated (NAI) | No citations listed |
| Feb 24, 2014 | Voluntary Action Indicated (VAI) | Lack of or inadequate procedures (21 CFR 820.100(a)) Quality Audit/Reaudit - conducted (21 CFR 820.22) Management review dates (21 CFR 820.20(c)) |
| Mar 10, 2011 | No Action Indicated (NAI) | No citations listed |
| Mar 10, 2011 | No Action Indicated (NAI) | No citations listed |
| Jun 11, 2009 | Voluntary Action Indicated (VAI) | Specific non-conforming product procedures (21 CFR 820.90(a)) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jul 20, 2023 | Class II | Z-0211-2024 | Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum… Reports were received the elastomer cup material is crumbling. |
| Sep 28, 2017 | Class II | Z-0741-2018 | Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock… Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material. |
FDA record score
3 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.
4 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Class II recall Z-0211-2024, this FEI as the recalling firm | Jul 20, 2023 | 4 x 0.6 | 2.4 |
| Class II recall Z-0741-2018, this FEI as the recalling firm | Sep 28, 2017 | 4 x 0.25 | 1 |
| Inspection classified VAI | Feb 24, 2014 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Jun 11, 2009 | 10 years or older, so it adds no points | 0 |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 15, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
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Facility details
- Company
- Cosmedent, Inc.
- Location
- CHICAGO, IL (US)
- Source
- device