FDA Inspection
Isomedix Operations, Inc.Isomedix Operations, Inc. – FDA Inspection, Jan 29, 2013
Record Details
This FDA Inspection record concerns Isomedix Operations, Inc., with an inspection on January 29, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Isomedix Operations, Inc.
- Inspection Date
- January 29, 2013
- Product Type
- Drugs
View Company Profile
ID · e286232e-76cc-46a4-b090-5a721f99090e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 816872
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
1- 21 CFR 211.192Extent of discrepancy, failure investigations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Isomedix Operations, Inc.
10| Date | Classification | Office | Project area |
|---|---|---|---|
| September 17, 2025 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 19, 2024 | Not classified | Chicago District Office | |
| February 7, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 30, 2017 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| November 15, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Isomedix Operations, Inc.
- FDA Inspection 1286590 - 2025-09-17
- FDA Inspection 1250741 - 2024-09-19
- FDA Inspection 1121544 - 2020-02-07
- FDA Inspection 1037072 - 2017-11-30
- FDA Inspection 993210 - 2016-11-15
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