Company
United StatesCytoTherm L.P., Trenton, NJ – FDA Inspections
Inspection records and compliance data for CytoTherm L.P. in Trenton, New Jersey. 4 FDA inspections on record, 1 Form 483, last inspected November 14, 2019.
Company Profile
This profile covers CytoTherm L.P. based in Trenton, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected March 9, 2011. Last inspected November 14, 2019.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- DHR content1 inspection
- Nonconforming product, Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 14, 2019 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1123811 |
| October 27, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 991419 |
| March 31, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 873309 |
| March 9, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 713076 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
CytoTherm L.P.
FEI Number
1000526879
Address
110 Sewell Ave, Trenton, New Jersey 08610, United States
Country
United States
ID: e15a9500-4b13-4cfc-9c38-616a8a7950fe