Company
United StatesPlastikon Healthcare LLC, Lawrence, KS – FDA Inspections
Inspection records and compliance data for Plastikon Healthcare LLC in Lawrence, Kansas. 5 FDA inspections on record (1 OAI), 1 Form 483, last inspected April 30, 2024.
Company Profile
This profile covers Plastikon Healthcare LLC based in Lawrence, Kansas, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 1
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected November 22, 2013. Last inspected April 30, 2024.
Most cited issue areas
- Annual visual exams of drug products1 inspection
- Backup file not maintained1 inspection
- Component identity verification1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 30, 2024 | NAI | Human Drugs · Drug Quality Assurance | 1229941 |
| January 12, 2023 | VAI | Foods & Cosmetics · Foodborne Biological Hazards | 1195398 |
| November 4, 2021 | OAI | Human Drugs · Drug Quality Assurance | 1156663 |
| October 28, 2016 | NAI | Foods & Cosmetics, Human Drugs, Medical Devices & Rad Health · Compliance: Devices | 990284 |
| November 22, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 858032 |
FDA documents
Form 483s (1)
People (1)
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Plastikon Healthcare LLC
FEI Number
3009840089
Address
3780 Greenway Cir, Lawrence, Kansas 66046, United States
Country
United States
ID: ee77c99e-ee0b-484d-923a-0cb39739bf8e