FEI 2025771
Biofilm, Inc.
3225 Executive Rdg, VISTA, CA, US
MDR events7All time
Recalls0All time
Registered products4
Establishment typeManufactureManufacture Medical Device
Registered product codes
4 product codes
Recent MDR events
7 on file
- ASTROGLIDE SPRAY 'N GLIDE PREMIUM SILICONE PERSONAL LUBRICANT SPRAYDec 22, 2023InjuryMW5149551
- ASTROGLIDENov 1, 2023InjuryMW5147661
- ASTROGLIDE ULTRA GENTLE GEL PERSONAL LUBRICANTJul 31, 2019InjuryMW5088567
- ASTROGLIDE ULTRA GENTLE GEL PERSONAL LUBRICANTFeb 8, 2019MW5083860
- ASTROGLIDE NATURAL PERSONAL LUBRICANTDec 22, 2015Injury2025771-2015-00001
- ASTROGLIDESep 30, 1998Injury2025771-1998-00001
- ASTROGLIDEOct 7, 1997Injury2025771-1997-00001
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 2025771.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)May 19, 2026
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)May 19, 2026
Postmarket Assurance: Devices · Citations posted
Inspection citations
1 on file
Top cited requirements
Compare to industry ↗- 21 CFR 803.50(a)(1)May 19, 2026
Report of Death or Serious Injury
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.