FDA Inspection
Biofilm, Inc.Biofilm, Inc. – FDA Inspection, Jun 1, 2011
Record Details
This FDA Inspection record concerns Biofilm, Inc., with an inspection on June 1, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Biofilm, Inc.
- Inspection Date
- June 1, 2011
- Product Type
- Devices
View Company Profile
ID · 47e1d78b-771b-4a1e-95d6-52d26aced4b8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 727215
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 803.17Lack of Written MDR 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 |
| May 25, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 14, 2011 | NAI | 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 1014535 - 2017-05-25
- FDA Inspection 745757 - 2011-09-14
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