Company
United StatesTekna Manufacturing, LLC, Zephyrhills, FL – FDA Inspections
Inspection records and compliance data for Tekna Manufacturing, LLC in Zephyrhills, Florida. 3 FDA inspections on record, 1 Form 483, last inspected February 28, 2017.
Company Profile
This profile covers Tekna Manufacturing, LLC based in Zephyrhills, Florida, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected July 22, 2013. Last inspected February 28, 2017.
Most cited issue areas
- Complaints1 inspection
- Design history file1 inspection
- DHR - not or inadequately maintained1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 28, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1006295 |
| April 29, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 876586 |
| July 22, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 841403 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
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Company Information
Name
Tekna Manufacturing, LLC
FEI Number
3002919078
Address
4920 Airport Rd, Zephyrhills, Florida 33542, United States
Country
United States
ID: 277c82c2-433a-4158-ba25-a197d328f702