FDA Inspection 1071697 — MEDICON, E.G.
The FDA completed an inspection of MEDICON, E.G. on Nov 15, 2018 in Tuttlingen. 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 15, 2018
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Tuttlingen (Germany)
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 |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |