FDA Inspection
Atlantic Health System (IRB)Atlantic Health System (IRB) – FDA Inspection, Jun 30, 2009
Record Details
This FDA Inspection record concerns Atlantic Health System (IRB), with an inspection on June 30, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Atlantic Health System (IRB)
- Inspection Date
- June 30, 2009
- Product Type
- Drugs
View Company Profile
ID · 2b7c4075-05d7-4ef4-820b-cac5ffec52a8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 595445
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 56.104(c)Emergency use and IRB approval
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Atlantic Health System (IRB)
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 27, 2025 | Not classified | New Jersey District Office | |
| February 16, 2017 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| January 11, 2013 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Atlantic Health System (IRB)
- FDA Inspection 1266178 - 2025-02-27
- FDA Inspection 1005200 - 2017-02-16
- FDA Inspection 815027 - 2013-01-11
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.