FDA Inspection 653221 — Ademco Inc.
The FDA completed an inspection of Ademco Inc. on February 23, 2010 in Louisville, KY. 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
- February 23, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Louisville, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2351 | 21 CFR 820.25(b) | Training |
| 3304 | 21 CFR 820.100(a)(5) | Changes to correct/prevent quality problems |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |