FDA Inspection
A. Rosenson Inc.A. Rosenson Inc. – FDA Inspection, Oct 27, 2009
Record Details
This FDA Inspection record concerns A. Rosenson Inc., with an inspection on October 27, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- A. Rosenson Inc.
- Inspection Date
- October 27, 2009
- Product Type
- Devices
View Company Profile
ID · ec0bc056-dcf7-4c1f-8452-346ca8030133
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 632952
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.72(b)(1)Calibration standard traceability
- 21 CFR 820.198(a)General
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of A. Rosenson Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 9, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for A. Rosenson Inc.
- FDA Inspection 790495 - 2012-07-09
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