FDA Inspection
Biomerica, Inc.Biomerica, Inc. – FDA Inspection, Feb 5, 2015
Record Details
This FDA Inspection record concerns Biomerica, Inc., with an inspection on February 5, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Biomerica, Inc.
- Inspection Date
- February 5, 2015
- Product Type
- Devices
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ID · 911c577a-9cc0-4ecf-b401-863c80654192
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 912808
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.80(e)Documentation
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Biomerica, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 20, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 20, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 28, 2008 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Biomerica, Inc.
- FDA Inspection 1239986 - 2024-05-20
- FDA Inspection 1113064 - 2019-11-20
- FDA Inspection 607364 - 2008-10-28
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