FDA Inspection 989187 — Glytec, LLC.
The FDA completed an inspection of Glytec, LLC. on August 18, 2016 in Greenville, SC. 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
- August 18, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Greenville, SC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3147 | 21 CFR 820.170(a) | Lack of or inadequate instructions |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 3323 | 21 CFR 820.170(b) | Installer records |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |