FDA Inspection
LK Precision ABLK Precision AB – FDA Inspection, Nov 19, 2025
Record Details
This FDA Inspection record concerns LK Precision AB, with an inspection on November 19, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 15f2407d-737e-40b9-8d32-995a30388ea0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1291884
- FDA center
- Medical Devices & Rad Health
- Project area
- Product Evaluation: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.75(a)Lack of or inadequate process validation
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