FDA Inspection
Almo-Erzeugnisse Erwin Busch GmbHAlmo-Erzeugnisse Erwin Busch GmbH – FDA Inspection, Apr 12, 2018
Record Details
This FDA Inspection record concerns Almo-Erzeugnisse Erwin Busch GmbH, with an inspection on April 12, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- April 12, 2018
- Product Type
- Medical Devices & Rad Health
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ID · 3639f8e2-6b61-42a8-aef1-949c1d24a996
Inspection Facts
- Inspection number
- 1050299
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Almo-Erzeugnisse Erwin Busch GmbH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 12, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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