FDA Inspection
Primasil Silicones LimitedPrimasil Silicones Limited – FDA Inspection, Mar 15, 2018
Record Details
This FDA Inspection record concerns Primasil Silicones Limited, with an inspection on March 15, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8dbe9095-0da6-4cd2-8e14-2d60d39cebe0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1046508
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
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Other FDA inspections of Primasil Silicones Limited
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 29, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Primasil Silicones Limited
- FDA Inspection 961114 - 2016-01-29
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