FDA Inspection 655718 — Medivators Inc
The FDA completed an inspection of Medivators Inc on April 13, 2010 in Conroe, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 13, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Conroe, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3284 | 21 CFR 820.90(a) | Nonconforming product evaluation/investigation |
| 3290 | 21 CFR 820.90(b)(2) | Retesting and reevaluation of reworked product |
| 3303 | 21 CFR 820.100(a)(4) | Verify, validate change {see also 820.100(a)} |
| 3380 | 21 CFR 820.198(e)(6) | Results of investigation |
| 3688 | 21 CFR 820.100(a)(1) | Analysis of data/reports from data sources |
| 3837 | 21 CFR 820.25(b) | Training records |