FDA Inspection 1240761 — Dental Technologies, Inc.
The FDA completed an inspection of Dental Technologies, Inc. on Aug 14, 2024 in Lincolnwood, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 14, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lincolnwood, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |