FDA Inspection 1092586 — TPC Advanced Technology Inc.
The FDA completed an inspection of TPC Advanced Technology Inc. on June 11, 2019 in City Of Industry, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 11, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- City Of Industry, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |