FDA Inspection 1016446 — Teledyne Analytical Instruments
The FDA completed an inspection of Teledyne Analytical Instruments on June 30, 2017 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). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 30, 2017
- Fiscal Year
- 2017
- 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 |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3232 | 21 CFR 820.72(a) | Equipment suitability & capability |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 4201 | 21 CFR 806.10(c)(8) | Illness report |