FDA Inspection 715890 — Electro Medical Equipment Co Inc
The FDA completed an inspection of Electro Medical Equipment Co Inc on Mar 22, 2011 in Prairieville, LA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 22, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Prairieville, LA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |