FDA Inspection
Peregrine Surgical LtdPeregrine Surgical Ltd – FDA Inspection, Jul 15, 2010
Record Details
This FDA Inspection record concerns Peregrine Surgical Ltd, with an inspection on July 15, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Peregrine Surgical Ltd
- Inspection Date
- July 15, 2010
- Product Type
- Devices
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ID · 45d4e7f6-d503-48da-bfbd-2fff77fb6c7d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 672519
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 812.7(a)Promotion or test marketing
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.30(e)Design review - documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Peregrine Surgical Ltd
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2018 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| June 27, 2018 | Not classified | Philadelphia District Office | |
| June 19, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 7, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 30, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Peregrine Surgical Ltd
- FDA Inspection 1069679 - 2018-09-26
- FDA Inspection 1079992 - 2018-06-27
- FDA Inspection 928467 - 2015-06-19
- FDA Inspection 817610 - 2013-02-07
- FDA Inspection 733958 - 2011-06-30
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