Company
United KingdomImmunodiagnostic Systems Limited, Boldon Colliery, United Kingdom – FDA Inspections
Inspection records and compliance data for Immunodiagnostic Systems Limited in Boldon Colliery. 4 FDA inspections on record, 2 Form 483s, last inspected January 10, 2019.
Company Profile
This profile covers Immunodiagnostic Systems Limited based in Boldon Colliery, United Kingdom.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected November 25, 2010. Last inspected January 10, 2019.
Most cited issue areas
- Design validation - user needs and intended uses2 inspections
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 10, 2019 | Not classified | Medical Devices & Rad Health | 1094823 |
| January 11, 2018 | Not classified | Medical Devices & Rad Health | 1051775 |
| July 30, 2015 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 938975 |
| November 25, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 701344 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Immunodiagnostic Systems Limited
FEI Number
3002485711
Address
10 Didcot Way, Boldon Colliery, United Kingdom
Country
United Kingdom
ID: 164f3286-2c4a-4d94-a640-ca67baacf8bf