Company
United StatesPeregrine Surgical Ltd, New Britain, PA – FDA Inspections
Inspection records and compliance data for Peregrine Surgical Ltd in New Britain, Pennsylvania. 6 FDA inspections on record (1 OAI), 1 Form 483, last inspected September 26, 2018.
Company Profile
This profile covers Peregrine Surgical Ltd based in New Britain, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 1
- VAI
- 3
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected July 15, 2010. Last inspected September 26, 2018.
Most cited issue areas
- Design history file1 inspection
- Design review - documentation1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 26, 2018 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1069679 |
| June 27, 2018 | Not classified | Medical Devices & Rad Health | 1079992 |
| June 19, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 928467 |
| February 7, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 817610 |
| June 30, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 733958 |
| July 15, 2010 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 672519 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Peregrine Surgical Ltd
FEI Number
1000121498
Address
51 Britain Dr, New Britain, Pennsylvania 18901, United States
Country
United States
ID: d847f313-f6de-44ba-abd5-8dde0d5c6693