FDA Inspection
Hard Manufacturing Co., Inc.Hard Manufacturing Co., Inc. – FDA Inspection, Mar 6, 2025
Record Details
This FDA Inspection record concerns Hard Manufacturing Co., Inc., with an inspection on March 6, 2025, issued by the New York District Office, covering medical devices & rad health.
- Company
- Hard Manufacturing Co., Inc.
- Inspection Date
- March 6, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 333b83aa-46a7-4512-8daa-70c92e298562
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1263486
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(c)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Hard Manufacturing Co., Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| April 7, 2026 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 24, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 18, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 7, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 28, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Hard Manufacturing Co., Inc.
- FDA Inspection 1311798 - 2026-04-07
- FDA Inspection 1163054 - 2022-02-24
- FDA Inspection 1083361 - 2019-03-18
- FDA Inspection 1003177 - 2017-03-07
- FDA Inspection 868183 - 2014-02-28
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