FDA Inspection
Chromsystems Instruments & Chemicals GmbHChromsystems Instruments & Chemicals GmbH – FDA Inspection, Mar 20, 2014
Record Details
This FDA Inspection record concerns Chromsystems Instruments & Chemicals GmbH, with an inspection on March 20, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 20, 2014
- Product Type
- Devices
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ID · 7f1e3b54-3bd6-4a57-96ff-6e2779daf8c8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 871086
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.250(b)Sampling plans
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Other FDA inspections of Chromsystems Instruments & Chemicals GmbH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 23, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Chromsystems Instruments & Chemicals GmbH
- FDA Inspection 977045 - 2016-06-23
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