Company
United StatesAccess Bio, Inc., Somerset, NJ – FDA Inspections
Inspection records and compliance data for Access Bio, Inc. in Somerset, New Jersey. 4 FDA inspections on record (3 OAI), last inspected September 27, 2016.
Company Profile
This profile covers Access Bio, Inc. based in Somerset, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 3
- VAI
- 0
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected May 25, 2010. Last inspected September 27, 2016.
Most cited issue areas
- DHR content1 inspection
- DMR - not or inadequately maintained1 inspection
- Document review, approval by designated individual1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 27, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 993227 |
| August 29, 2011 | OAI | Medical Devices & Rad Health · Compliance: Devices | 734128 |
| August 31, 2010 | OAI | Medical Devices & Rad Health · Compliance: Devices | 675952 |
| May 25, 2010 | OAI | Medical Devices & Rad Health · Compliance: Devices | 664896 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Access Bio, Inc.
FEI Number
3008474767
Address
65 Clyde Rd Ste A, Somerset, New Jersey 08873, United States
Country
United States
ID: 5c50259d-f24b-4895-a5e6-14c1577ac8eb