FDA Inspection 700970 — Medical Laser Systems Inc
The FDA completed an inspection of Medical Laser Systems Inc on Dec 14, 2010 in Branford, CT. 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
- Dec 14, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Branford, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |