FDA Inspection 966726 — ALR Technologies, Inc.
The FDA completed an inspection of ALR Technologies, Inc. on March 22, 2016 in North Chesterfield, VA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 13 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 22, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- North Chesterfield, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 502 | 21 CFR 820.60 | Identification procedures, Lack of or inadequate procedures |