Company
United StatesBio-Med U.S.A., Inc., Paterson, NJ – FDA Inspections
Inspection records and compliance data for Bio-Med U.S.A., Inc. in Paterson, New Jersey. 2 FDA inspections on record, last inspected January 23, 2013.
Company Profile
This profile covers Bio-Med U.S.A., Inc. based in Paterson, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected July 19, 2010. Last inspected January 23, 2013.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of Written MDR Procedures1 inspection
- Purchasing controls, Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 23, 2013 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 816798 |
| July 19, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 672514 |
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
Bio-Med U.S.A., Inc.
FEI Number
2246683
Address
129 Market St, Paterson, New Jersey 07505, United States
Country
United States
ID: 71f22d1b-0562-470c-a782-552e533afd55