Company
United StatesOrtho-Clinical Diagnostics, Rochester, NY – FDA Inspections
Inspection records and compliance data for Ortho-Clinical Diagnostics in Rochester, New York. 1 FDA inspection on record, 1 Form 483, last inspected March 31, 2017.
Company Profile
This profile covers Ortho-Clinical Diagnostics based in Rochester, New York, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected March 31, 2017.
Most cited issue areas
- Design verification - output does not meet input requirement1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 31, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1013474 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Ortho-Clinical Diagnostics
FEI Number
1000305841
Address
1000 Lee Rd, Rochester, New York 14606, United States
Country
United States
ID: 33273924-54f5-4893-8f81-a42f5b678b9d