FDA Inspection
Angstrom Mfg IncAngstrom Mfg Inc – FDA Inspection, Aug 12, 2026
Record Details
This FDA Inspection record concerns Angstrom Mfg Inc, with an inspection on August 12, 2026, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Angstrom Mfg Inc
- Inspection Date
- August 12, 2026
- Product Type
- Devices
View Company Profile
ID · d4701199-ce95-4678-b148-de2bb4e1efff
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1330686
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 830Devices subject to device identification GUDID data submission requirements.
- ISO 13485:2016 Clause 7.1Records of risk management activities in product realization not maintained
- ISO 13485:2016 Clause 7.5.1Production and service provision not adequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Angstrom Mfg Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 17, 2016 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| June 8, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Angstrom Mfg Inc
- FDA Inspection 994001 - 2016-11-17
- FDA Inspection 729505 - 2011-06-08
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