FDA Inspection 1171683 — Sonoco TEQ Llc
The FDA completed an inspection of Sonoco TEQ Llc on Jun 10, 2022 in Fremont, IN. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jun 10, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Fremont, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3232 | 21 CFR 820.72(a) | Equipment suitability & capability |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |