FDA Inspection 1071189 — WEBER MEDICAL GMBH
The FDA completed an inspection of WEBER MEDICAL GMBH on November 8, 2018 in Lauenforde. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 15 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 8, 2018
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Lauenforde (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate 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 |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 5032 | 21 CFR 1010.2(b) | Certification label or tag |
| 5153 | 21 CFR 1040.10(f)(5)(ii) | Emission indicator - Class IIIb & IV |
| 5199 | 21 CFR 1040.10(h)(1)(iii) | Legible reproductions |
| 5200 | 21 CFR 1040.10(h)(1)(iv) | User info - list controls, etc. |
| 5203 | 21 CFR 1040.10(h)(2)(i) | Reproduction of affixed information |
| 5209 | 21 CFR 1040.11(a)(3) | Aperture label |
| 633 | 21 CFR 803.17(a)(3) | Lack of System for Timely Submission of Reports |