FDA Inspection
Alpha Source LLCAlpha Source LLC – FDA Inspection, Feb 2, 2018
Record Details
This FDA Inspection record concerns Alpha Source LLC, with an inspection on February 2, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 29f4ff57-b7b7-4bbd-a963-810978cc2c06
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1039995
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.86Acceptance status
- 21 CFR 820.30(g)Design validation - simulated testing
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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Other FDA inspections of Alpha Source LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 11, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Alpha Source LLC
- FDA Inspection 925725 - 2015-05-11
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