Company
United StatesWayne Concept Manufacturing Co., Inc., Fort Wayne, IN – FDA Inspections
Inspection records and compliance data for Wayne Concept Manufacturing Co., Inc. in Fort Wayne, Indiana. 4 FDA inspections on record, 1 Form 483, last inspected March 29, 2018.
Company Profile
This profile covers Wayne Concept Manufacturing Co., Inc. based in Fort Wayne, Indiana, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 4
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected April 30, 2010. Last inspected March 29, 2018.
Most cited issue areas
- Lack of written stability program4 inspections
- Procedures not in writing, fully followed4 inspections
- Reports of Analysis (Components)4 inspections
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 29, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1045956 |
| November 19, 2015 | VAI | Human Drugs · Drug Quality Assurance | 953175 |
| January 10, 2013 | VAI | Human Drugs · Drug Quality Assurance | 814166 |
| April 30, 2010 | VAI | Human Drugs · Drug Quality Assurance | 661205 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Wayne Concept Manufacturing Co., Inc.
FEI Number
3002251297
Address
5005 Speedway Dr, Fort Wayne, Indiana 46825, United States
Country
United States
ID: a552dd82-4b23-4e61-80c2-e37a92a9d948