FDA Inspection
Saint-Gobain Performance PlasticsSaint-Gobain Performance Plastics – FDA Inspection, Jun 17, 2009
Record Details
This FDA Inspection record concerns Saint-Gobain Performance Plastics, with an inspection on June 17, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 17, 2009
- Product Type
- Devices
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ID · 330262ab-51b7-484f-9cce-7a0aeb543a94
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 590423
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)General
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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