FDA Inspection 636051 — Electromedical Products International, Inc.
The FDA completed an inspection of Electromedical Products International, Inc. on December 18, 2009 in Mineral Wells, 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
- December 18, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Mineral Wells, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3157 | 21 CFR 820.181(c) | DMR QA procedures and specifications |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3283 | 21 CFR 820.90(a) | Specific non-conforming product procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3355 | 21 CFR 820.198(f) | Records accessibility |
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |
| 3379 | 21 CFR 820.198(e)(5) | Nature and details of complaint |
| 3667 | 21 CFR 820.20(c) | Management review accomplishment |
| 3696 | 21 CFR 820.100(b) | Documentation |