FDA Inspection
Waldemar Link GmbH & Co. KG (Mfg Site)Waldemar Link GmbH & Co. KG (Mfg Site) – FDA Inspection, May 11, 2023
Record Details
This FDA Inspection record concerns Waldemar Link GmbH & Co. KG (Mfg Site), with an inspection on May 11, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · eba4fb80-817f-4135-9cd0-838c8b6dac9b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1206902
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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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 | |
| January 22, 2015 | VAI | Center for Devices and Radiological Health | Compliance: 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 911197 - 2015-01-22
- FDA Inspection 792790 - 2012-07-26
- FDA Inspection 696404 - 2010-09-16
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