Company
United StatesKatena Products, Inc., Randolph, NJ – FDA Inspections
Inspection records and compliance data for Katena Products, Inc. in Randolph, New Jersey. 7 FDA inspections on record, 1 Form 483, last inspected March 01, 2024.
Company Profile
This profile covers Katena Products, Inc. based in Randolph, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 1
- NAI
- 5
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected November 9, 2009. Last inspected March 1, 2024.
Most cited issue areas
- Purchasing controls, Lack of or inadequate procedures1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 1, 2024 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1234623 |
| January 6, 2020 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1114594 |
| September 20, 2018 | Not classified | Medical Devices & Rad Health | 1123022 |
| September 12, 2017 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1026619 |
| August 31, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 986240 |
| February 22, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 768294 |
| November 9, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 629009 |
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
Katena Products, Inc.
FEI Number
2242450
Address
4 Middlebury Blvd Ste 1, Randolph, New Jersey 07869, United States
Country
United States
ID: 263ef7d5-d73c-4f31-8090-95297c342713