Company
United StatesMirion Technologies (Capintec), Inc., Florham Park, NJ – FDA Inspections
Inspection records and compliance data for Mirion Technologies (Capintec), Inc. in Florham Park, New Jersey. 4 FDA inspections on record, last inspected August 16, 2019.
Company Profile
This profile covers Mirion Technologies (Capintec), Inc. based in Florham Park, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected December 8, 2010. Last inspected August 16, 2019.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures - Acceptance activities1 inspection
- Rationale documented for no investigation1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 16, 2019 | Not classified | Medical Devices & Rad Health | 1127776 |
| January 25, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 960337 |
| January 23, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 815182 |
| December 8, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 702065 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Mirion Technologies (Capintec), Inc.
FEI Number
2518443
Address
7 Vreeland Rd, Florham Park, New Jersey 07932, United States
Country
United States
ID: 524d44ba-94e8-449b-b6cc-dc23e9fb175f