Company
United StatesHard Manufacturing Co., Inc., Buffalo, NY – FDA Inspections
Inspection records and compliance data for Hard Manufacturing Co., Inc. in Buffalo, New York. 7 FDA inspections on record, 3 Form 483s, last inspected April 07, 2026.
Company Profile
This profile covers Hard Manufacturing Co., Inc. based in Buffalo, New York, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 4
- NAI
- 3
- Form 483s
- 3
- Warning letters
- 0
First inspected July 7, 2011. Last inspected April 7, 2026.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Design control - no procedures1 inspection
- Documentation1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 7, 2026 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1311798 |
| March 6, 2025 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1263486 |
| February 24, 2022 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1163054 |
| March 18, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1083361 |
| March 7, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1003177 |
| February 28, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 868183 |
| July 7, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 737022 |
FDA documents
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Hard Manufacturing Co., Inc.
FEI Number
1317511
Address
230 Grider St, Buffalo, New York 14215, United States
Country
United States
ID: d76bb2f8-d74d-46fd-a552-22631a4ba5d0