Company
United StatesGreenwald Surgical Company, Inc., Lake Station, IN – FDA Inspections
Inspection records and compliance data for Greenwald Surgical Company, Inc. in Lake Station, Indiana. 4 FDA inspections on record, 1 Form 483, last inspected March 15, 2018.
Company Profile
This profile covers Greenwald Surgical Company, Inc. based in Lake Station, Indiana, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected September 20, 2011. Last inspected March 15, 2018.
Most cited issue areas
- DHR - not or inadequately maintained1 inspection
- Lack of or inadequate final acceptance procedures1 inspection
- Nonconforming product control1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 15, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1044946 |
| September 17, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 898361 |
| September 27, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 800967 |
| September 20, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 745573 |
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
Greenwald Surgical Company, Inc.
FEI Number
1818662
Address
2688 Dekalb St, Lake Station, Indiana 46405, United States
Country
United States
ID: 5e327bd1-6f0b-4b7f-b826-8a8e187cb98a