Company
United StatesMaineHealth IRB #1, Portland, ME – FDA Inspections
Inspection records and compliance data for MaineHealth IRB #1 in Portland, Maine. 3 FDA inspections on record, last inspected March 24, 2022.
Company Profile
This profile covers MaineHealth IRB #1 based in Portland, Maine, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected February 12, 2010. Last inspected March 24, 2022.
Most cited issue areas
- Factors required for approval1 inspection
- IRB review requirement1 inspection
- Minor changes1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 24, 2022 | NAI | Biologics, Human Drugs, Medical Devices & Rad Health · Bioresearch Monitoring | 1167287 |
| March 16, 2016 | VAI | Human Drugs, Medical Devices & Rad Health · Bioresearch Monitoring | 962618 |
| February 12, 2010 | VAI | Human Drugs · Bioresearch Monitoring | 648126 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
MaineHealth IRB #1
FEI Number
3003354649
Address
509 Forest Ave Ste 350, Portland, Maine 04101, United States
Country
United States
ID: c20e5d7b-a543-410b-b31e-2db3cea4f2ad