Company
United StatesBiofilm, Inc., Vista, CA – FDA Inspections
Inspection records and compliance data for Biofilm, Inc. in Vista, California. 5 FDA inspections on record, 3 Form 483s, last inspected May 19, 2026.
Company Profile
This profile covers Biofilm, Inc. based in Vista, California, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 3
- Warning letters
- 0
First inspected June 1, 2011. Last inspected May 19, 2026.
Most cited issue areas
- Design transfer - Lack of or inadequate procedures1 inspection
- Design validation - user needs and intended uses1 inspection
- Documentation1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 19, 2026 | Not classified | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1318370 |
| June 15, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1210051 |
| May 25, 2017 | VAI | Human Drugs, Medical Devices & Rad Health · Compliance: Devices | 1014535 |
| September 14, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 745757 |
| June 1, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 727215 |
FDA documents
Form 483s (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Biofilm, Inc.
FEI Number
2025771
Address
3225 Executive Rdg, Vista, California 92081, United States
Country
United States
ID: 97b5de6b-0281-4eb7-afab-5a0f5dbde1f0