FDA Inspection
Hard Manufacturing Co., Inc.Hard Manufacturing Co., Inc. – FDA Inspection, Mar 7, 2017
Record Details
This FDA Inspection record concerns Hard Manufacturing Co., Inc., with an inspection on March 7, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5c893099-945e-47a8-9f72-b4149b5a1e6c
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1003177
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.198(b)Rationale documented for no investigation
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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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 |
| 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 |
| 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 1263486 - 2025-03-06
- FDA Inspection 1163054 - 2022-02-24
- FDA Inspection 1083361 - 2019-03-18
- FDA Inspection 868183 - 2014-02-28
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