FDA Inspection
Alera Technologies, Inc.Alera Technologies, Inc. – FDA Inspection, Nov 6, 2025
Record Details
This FDA Inspection record concerns Alera Technologies, Inc., with an inspection on November 6, 2025, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ce679c79-b18d-4858-9a46-addf00b2b833
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1290292
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.80(c)Documentation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.70(g)Equipment Installation, Placement, Specified Requirements
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Alera Technologies, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 6, 2017 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| April 16, 2014 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| June 10, 2011 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| May 20, 2009 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for Alera Technologies, Inc.
- FDA Inspection 1015920 - 2017-04-06
- FDA Inspection 875664 - 2014-04-16
- FDA Inspection 730835 - 2011-06-10
- FDA Inspection 583050 - 2009-05-20
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