FDA Inspection
Christoph Miethke GmbH & Co. KGChristoph Miethke GmbH & Co. KG – FDA Inspection, Jun 27, 2019
Record Details
This FDA Inspection record concerns Christoph Miethke GmbH & Co. KG, with an inspection on June 27, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- June 27, 2019
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 97fc8639-6f18-45ef-8997-da8ccf0bbcde
Inspection Facts
- Inspection number
- 1097330
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.80(e)Documentation
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
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