FDA Inspection
Waldemar Link GmbH & Co. KG (Mfg Site)Waldemar Link GmbH & Co. KG (Mfg Site) – FDA Inspection, Jan 22, 2015
Record Details
This FDA Inspection record concerns Waldemar Link GmbH & Co. KG (Mfg Site), with an inspection on January 22, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 22, 2015
- Product Type
- Devices
View Company Profile
ID · 28702254-2e3d-4183-9fcb-d2ad1923b938
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 911197
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Waldemar Link GmbH & Co. KG (Mfg Site)
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 19, 2026 | Not classified | Office of Inspections and Investigations | |
| May 11, 2023 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 26, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 16, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Waldemar Link GmbH & Co. KG (Mfg Site)
- FDA Inspection 1310346 - 2026-02-19
- FDA Inspection 1206902 - 2023-05-11
- FDA Inspection 792790 - 2012-07-26
- FDA Inspection 696404 - 2010-09-16
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