FDA Inspection
KLS Martin GmbH & Co. KGKLS Martin GmbH & Co. KG – FDA Inspection, May 25, 2017
Record Details
This FDA Inspection record concerns KLS Martin GmbH & Co. KG, with an inspection on May 25, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · e87a4183-8457-47b8-a85d-a9ec98249f61
Inspection Facts
- Inspection number
- 1016260
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
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