FDA Inspection 1095737 — Titronics Research & Development Co.
The FDA completed an inspection of Titronics Research & Development Co. on Jul 9, 2019 in Tiffin, IA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 9, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Tiffin, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3236 | 21 CFR 820.72(b) | Calibration procedures - content |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |