FDA Inspection
Promega Biosystems Sunnyvale, Inc.Promega Biosystems Sunnyvale, Inc. – FDA Inspection, Oct 8, 2010
Record Details
This FDA Inspection record concerns Promega Biosystems Sunnyvale, Inc., with an inspection on October 8, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 8, 2010
- Product Type
- Devices
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ID · 9564478b-4ea1-4987-8398-da73a3b36fb0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 685366
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.100(b)Documentation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
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