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FDA Inspection
•raro plastics gmbh•October 26, 2017

raro plastics gmbh – FDA Inspection, Oct 26, 2017

Record Details

This FDA Inspection record concerns raro plastics gmbh, with an inspection on October 26, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company
raro plastics gmbh
Inspection Date
October 26, 2017
Product Type
Medical Devices & Rad Health
Office
Office of Inspections and Investigations
Person
  • Stephen D. Eich (Company Rep)
View Company Profile

ID · 906dd82d-1de8-410e-bb47-30fb7d93dac5

Inspection Facts

Inspection number
1031379
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 820.184DHR content
  2. 21 CFR 820.75(a)Lack of or inadequate process validation

Full citation text and observation details available on the Dashboard.

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