FDA Inspection
Haag-Streit USA IncHaag-Streit USA Inc – FDA Inspection, Mar 7, 2017
Record Details
This FDA Inspection record concerns Haag-Streit USA Inc, with an inspection on March 7, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 4ae8ec54-de49-40e9-89e7-73018a283790
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1005992
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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