FDA Inspection
Clearstream Technologies LtdClearstream Technologies Ltd – FDA Inspection, Jan 31, 2019
Record Details
This FDA Inspection record concerns Clearstream Technologies Ltd, with an inspection on January 31, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ed210896-c226-4257-9745-619b01348afe
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1078231
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
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Other FDA inspections of Clearstream Technologies Ltd
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 10, 2026 | Not classified | Office of Inspections and Investigations | |
| April 21, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Clearstream Technologies Ltd
- FDA Inspection 1336196 - 2026-09-10
- FDA Inspection 968495 - 2016-04-21
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