FDA Inspection 670603 — Rite-dent Manufacturing Corp.
The FDA completed an inspection of Rite-dent Manufacturing Corp. on July 8, 2010 in Hialeah, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 23 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 8, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Hialeah, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2293 | 21 CFR 820.20(d) | Quality plan |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3159 | 21 CFR 820.184 | DHR content |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3190 | 21 CFR 820.30(g) | Design validation acceptance criteria |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 3270 | 21 CFR 820.80(c) | Documentation |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 3837 | 21 CFR 820.25(b) | Training records |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |