FDA Inspection 1052273 — Teco Diagnostics, Inc.
The FDA completed an inspection of Teco Diagnostics, Inc. on May 9, 2018 in Anaheim, 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
- May 9, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Anaheim, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 633 | 21 CFR 803.17(a)(3) | Lack of System for Timely Submission of Reports |
| 635 | 21 CFR 803.17(b)(1) | Info evaluated to determine if event was reportable |