FDA Inspection
Hard Manufacturing Co., Inc.Hard Manufacturing Co., Inc. – FDA Inspection, Apr 7, 2026
Record Details
This FDA Inspection record concerns Hard Manufacturing Co., Inc., with an inspection on April 7, 2026, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d6ca12ad-939f-440a-a9a3-60ce805c0ccf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1311798
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- ISO 13485:2016 Clause 7.3.9Procedures to control design and development changes not documented
- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Hard Manufacturing Co., Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| March 6, 2025 | NAI | New York District Office | Postmarket Assurance: Medical 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 1263486 - 2025-03-06
- 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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