Company
United StatesFUSION SURGICAL, Orangeburg, NY – FDA Inspections
Inspection records and compliance data for FUSION SURGICAL in Orangeburg, New York. 1 FDA inspection on record, 1 Form 483, last inspected January 10, 2018.
Company Profile
This profile covers FUSION SURGICAL based in Orangeburg, New York, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected January 10, 2018.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design verification - output does not meet input requirement1 inspection
- DHR - not or inadequately maintained1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 10, 2018 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1037248 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
FUSION SURGICAL
FEI Number
3011392385
Address
30 Ramland Rd, Orangeburg, New York 10962, United States
Country
United States
ID: 284b85ec-28c5-4709-8381-01ae57c9ad3e