FDA Inspection
Sterling Diagnostics, Inc.Sterling Diagnostics, Inc. – FDA Inspection, Aug 13, 2010
Record Details
This FDA Inspection record concerns Sterling Diagnostics, Inc., with an inspection on August 13, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sterling Diagnostics, Inc.
- Inspection Date
- August 13, 2010
- Product Type
- Devices
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ID · ed35aa00-b235-429a-96a7-bcb76907af66
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 676805
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sterling Diagnostics, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 20, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 28, 2016 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 16, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Sterling Diagnostics, Inc.
- FDA Inspection 1035513 - 2017-12-20
- FDA Inspection 980678 - 2016-07-28
- FDA Inspection 859085 - 2013-12-16
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