FDA Inspection
International Immuno-Diagnostics Inc.International Immuno-Diagnostics Inc. – FDA Inspection, May 18, 2010
Record Details
This FDA Inspection record concerns International Immuno-Diagnostics Inc., with an inspection on May 18, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 18, 2010
- Product Type
- Devices
View Company Profile
ID · d17d89e2-68d8-4157-a8da-c594acd0f679
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 663760
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.160(a)Lack of or inadequate procedures for distribution
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.86Acceptance status
Showing 10 of 11 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of International Immuno-Diagnostics Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 31, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 23, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 3, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 7, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for International Immuno-Diagnostics Inc.
- FDA Inspection 920347 - 2015-03-31
- FDA Inspection 764800 - 2012-01-23
- FDA Inspection 701858 - 2011-01-03
- FDA Inspection 542096 - 2009-01-07
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.