FDA Inspection
Angstrom Manufacturing, Inc.Angstrom Manufacturing, Inc. – FDA Inspection, Aug 12, 2026
Record Details
This FDA Inspection record concerns Angstrom Manufacturing, Inc., with an inspection on August 12, 2026, issued by the Center for Devices and Radiological Health, covering medical devices & rad health.
- Company
- Angstrom Manufacturing, Inc.
- Inspection Date
- August 12, 2026
- Product Type
- Medical Devices & Rad Health
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
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 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
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
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Other FDA inspections of Angstrom Manufacturing, 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 Manufacturing, Inc.
- FDA Inspection 994001 - 2016-11-17
- FDA Inspection 729505 - 2011-06-08
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