FDA Inspection 851416 — Lifewatch Services Inc
The FDA completed an inspection of Lifewatch Services Inc on September 26, 2013 in Rosemont, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 26, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Rosemont, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2269 | 21 CFR 820.20(a) | Quality policy and objectives |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |