FDA Inspection
Biofilm, Inc.Biofilm, Inc. – FDA Inspection, May 25, 2017
Record Details
This FDA Inspection record concerns Biofilm, Inc., with an inspection on May 25, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b382e90c-4223-48ee-99ae-2809175f0f40
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1014535
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Biofilm, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 19, 2026 | Not classified | Los Angeles District Office | Postmarket Assurance: Devices |
| June 15, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 14, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 1, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Biofilm, Inc.
- FDA Inspection 1318370 - 2026-05-19
- FDA Inspection 1210051 - 2023-06-15
- FDA Inspection 745757 - 2011-09-14
- FDA Inspection 727215 - 2011-06-01
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