FDA Inspection
Bit Analytical Instruments GmbhBit Analytical Instruments Gmbh – FDA Inspection, Nov 17, 2016
Record Details
This FDA Inspection record concerns Bit Analytical Instruments Gmbh, with an inspection on November 17, 2016, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- November 17, 2016
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · f7ac27ad-aa07-439e-9c75-462694fbbff3
Inspection Facts
- Inspection number
- 993919
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.80(e)Documentation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
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Other FDA inspections of Bit Analytical Instruments Gmbh
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 3, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Bit Analytical Instruments Gmbh
- FDA Inspection 669147 - 2010-06-03
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