FDA Inspection 1095446 — Ad-Tech Medical Instrument Corporation
The FDA completed an inspection of Ad-Tech Medical Instrument Corporation on June 27, 2019 in Oak Creek, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 27, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Oak Creek, WI (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 |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 3699 | 21 CFR 820.160(b) | Distribution records |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 512 | 21 CFR 820.65 | Traceability Lack of or inadequate {see also 820.120(e)} |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |