FDA Inspection
Haag Streit U.K. LimitedHaag Streit U.K. Limited – FDA Inspection, Mar 1, 2012
Record Details
This FDA Inspection record concerns Haag Streit U.K. Limited, with an inspection on March 1, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Haag Streit U.K. Limited
- Inspection Date
- March 1, 2012
- Product Type
- Devices
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ID · e5091b64-e5a9-453e-919d-bad57bb4ada0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 770926
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.25(b)Training records
- 21 CFR 820.70(i)Software validation for automated processes
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Other FDA inspections of Haag Streit U.K. Limited
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 14, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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