FDA Inspection
Boss Instruments, Ltd.Boss Instruments, Ltd. – FDA Inspection, Jun 28, 2018
Record Details
This FDA Inspection record concerns Boss Instruments, Ltd., with an inspection on June 28, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8d1a192d-2636-41f1-9c6e-ca6d7394a94f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1057387
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audits - defined intervals
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Other FDA inspections of Boss Instruments, Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 21, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Boss Instruments, Ltd.
- FDA Inspection 730785 - 2011-06-21
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