Company
United StatesGraphic Controls Acquisition Corporation, Buffalo, NY – FDA Inspections
Inspection records and compliance data for Graphic Controls Acquisition Corporation in Buffalo, New York. 8 FDA inspections on record, 1 Form 483, last inspected February 23, 2021.
Company Profile
This profile covers Graphic Controls Acquisition Corporation based in Buffalo, New York, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 2
- NAI
- 6
- Form 483s
- 1
- Warning letters
- 0
First inspected December 16, 2010. Last inspected February 23, 2021.
Most cited issue areas
- Lack of or inadequate In-process acceptance procedures1 inspection
- Lack of or inadequate procedures1 inspection
- Maintenance schedule, Lack of or inadequate schedule1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 23, 2021 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1135942 |
| May 14, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1051938 |
| January 26, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1040302 |
| December 5, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 905863 |
| June 11, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 883433 |
| August 22, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 845536 |
| November 30, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 757179 |
| December 16, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 702279 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Graphic Controls Acquisition Corporation
FEI Number
1317188
Address
400 Exchange St, Buffalo, New York 14204, United States
Country
United States
ID: 90ae2198-9a67-4d7e-87fb-0b9504b0ad29