FDA Inspection
Hard Manufacturing Co., Inc.Hard Manufacturing Co., Inc. – FDA Inspection, Mar 18, 2019
Record Details
This FDA Inspection record concerns Hard Manufacturing Co., Inc., with an inspection on March 18, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f6f0b4f5-65c5-43af-97b5-2a5af377530a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1083361
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.70(g)(2)Periodic equipment inspection lack of or inadequate procedu
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
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 |
| 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 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 1263486 - 2025-03-06
- FDA Inspection 1163054 - 2022-02-24
- FDA Inspection 1003177 - 2017-03-07
- FDA Inspection 868183 - 2014-02-28
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