FDA Inspection 696404 — Waldemar Link GmbH & Co. KG (Mfg Site)
The FDA completed an inspection of Waldemar Link GmbH & Co. KG (Mfg Site) on September 16, 2010 in Norderstedt. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 16, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Norderstedt (Germany)
Additional Details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 3671 | 21 CFR 820.25(a) | Personnel |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |