FDA Inspection 981931 — NARVA Lichtquelle GmbH + Co. KG
The FDA completed an inspection of NARVA Lichtquelle GmbH + Co. KG on July 29, 2016 in Berlin. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 29, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Berlin (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3111 | 21 CFR 820.70(f) | Buildings |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 3237 | 21 CFR 820.72(b) | Remedial action |
| 3266 | 21 CFR 820.86 | Acceptance status |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |