FDA Inspection
Revvity Health Sciences IncRevvity Health Sciences Inc – FDA Inspection, Aug 10, 2012
Record Details
This FDA Inspection record concerns Revvity Health Sciences Inc, with an inspection on August 10, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Revvity Health Sciences Inc
- Inspection Date
- August 10, 2012
- Product Type
- Devices
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ID · b3393e77-ec6b-4191-bcea-a730b8495be0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 794651
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
11- 21 CFR 806.20(b)(5)Records of communications
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.70(g)Equipment design and installation
- 21 CFR 820.25(b)Training records
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
Showing 10 of 11 citations.
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Other FDA inspections of Revvity Health Sciences Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 15, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 18, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 4, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Revvity Health Sciences Inc
- FDA Inspection 1101003 - 2019-05-15
- FDA Inspection 917400 - 2015-02-18
- FDA Inspection 621073 - 2009-08-04
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