FDA Inspection
Isomedix Operations Inc.Isomedix Operations Inc. – FDA Inspection, Mar 21, 2012
Record Details
This FDA Inspection record concerns Isomedix Operations Inc., with an inspection on March 21, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Isomedix Operations Inc.
- Inspection Date
- March 21, 2012
- Product Type
- Devices
View Company Profile
ID · a6877758-655b-4e45-ae94-845f89fdb1e6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 774053
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 211.100(b)SOPs not followed / documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Isomedix Operations Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| May 15, 2025 | Not classified | Denver District Office | |
| July 2, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 27, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 13, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 11, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Isomedix Operations Inc.
- FDA Inspection 1269908 - 2025-05-15
- FDA Inspection 1095335 - 2019-07-02
- FDA Inspection 1077482 - 2018-11-27
- FDA Inspection 914481 - 2015-02-13
- FDA Inspection 714109 - 2011-03-11
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