FDA Inspection 1206902 — Waldemar Link GmbH & Co. KG
The FDA completed an inspection of Waldemar Link GmbH & Co. KG on May 11, 2023 in Norderstedt. 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
- May 11, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Norderstedt (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 4192 | 21 CFR 806.10(a)(2) | Report of violation of the Act (see 803.52(e)(9)) |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |