FDA Inspection 927940 — GNJ Ent Inc
The FDA completed an inspection of GNJ Ent Inc on Jun 10, 2015 in Chicago, IL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jun 10, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Chicago, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 3837 | 21 CFR 820.25(b) | Training records |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |