FDA Inspection
Medical Alignment SystemsMedical Alignment Systems – FDA Inspection, Mar 24, 2017
Record Details
This FDA Inspection record concerns Medical Alignment Systems, with an inspection on March 24, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9b9659d7-03ec-4d86-80c8-ad4b0d459466
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1006255
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 1002.13Failure to submit
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Medical Alignment Systems
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 17, 2010 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for Medical Alignment Systems
- FDA Inspection 671053 - 2010-06-17
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