FDA Inspection 566785 — Medivators Inc
The FDA completed an inspection of Medivators Inc on March 13, 2009 in Conroe, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 16 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 13, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Conroe, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2269 | 21 CFR 820.20(a) | Quality policy and objectives |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2429 | 21 CFR 820.30(b) | Establish the design and development plan |
| 2556 | 21 CFR 820.30(c) | Incomplete, ambiguous, conflicting design requirements |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 3204 | 21 CFR 820.40(b) | Change records, content |
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |
| 3300 | 21 CFR 820.100(a)(1) | Statistical methodology |
| 3346 | 21 CFR 820.200(b) | Analyzing service report |
| 3380 | 21 CFR 820.198(e)(6) | Results of investigation |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 3837 | 21 CFR 820.25(b) | Training records |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |
| 4189 | 21 CFR 820.198(a) | General |