FDA Inspection
Stingray Surgical Products, LLCStingray Surgical Products, LLC – FDA Inspection, Dec 5, 2011
Record Details
This FDA Inspection record concerns Stingray Surgical Products, LLC, with an inspection on December 5, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 5, 2011
- Product Type
- Devices
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ID · ac8769bc-e491-48c8-8197-517988c9a05b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 755796
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of Stingray Surgical Products, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| December 11, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 9, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 20, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 22, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 7, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Stingray Surgical Products, LLC
- FDA Inspection 1257464 - 2024-12-11
- FDA Inspection 1196975 - 2023-02-09
- FDA Inspection 1113802 - 2019-12-20
- FDA Inspection 996562 - 2016-11-22
- FDA Inspection 810201 - 2012-12-07
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