FDA Inspection 603326 — Sirona Dental, Inc
The FDA completed an inspection of Sirona Dental, Inc on August 4, 2009 in Long Island City, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 4, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Long Island City, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2628 | 21 CFR 820.30(e) | Design review procedures - personnel |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3149 | 21 CFR 820.180 | Availability |
| 3151 | 21 CFR 820.180 | Legibility |
| 3237 | 21 CFR 820.72(b) | Remedial action |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |
| 3333 | 21 CFR 820.184(f) | Device identification, control numbers |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |
| 633 | 21 CFR 803.17(a)(3) | Lack of System for Timely Submission of Reports |