FDA Inspection
PB-Kunststoffverarbeitung ballerstedt GmbhPB-Kunststoffverarbeitung ballerstedt Gmbh – FDA Inspection, Apr 26, 2018
Record Details
This FDA Inspection record concerns PB-Kunststoffverarbeitung ballerstedt Gmbh, with an inspection on April 26, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- April 26, 2018
- Product Type
- Medical Devices & Rad Health
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ID · ec71ebb6-bb20-4fa3-a5d1-a8d6cfb50e1a
Inspection Facts
- Inspection number
- 1050405
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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Other FDA inspections of PB-Kunststoffverarbeitung ballerstedt Gmbh
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 18, 2024 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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