FDA Inspection 887954 — New Horizons Diagnostic Corporation
The FDA completed an inspection of New Horizons Diagnostic Corporation on Jul 21, 2014 in Baltimore, MD. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jul 21, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Baltimore, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3837 | 21 CFR 820.25(b) | Training records |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |