# Biofilm, Inc. – FDA 483, May 19, 2026

Source: https://www.keypedia.com/records/483/biofilm-inc/ab3cdc15-a646-4746-a86b-eeeaf87f6730

> FDA 483 for Biofilm, Inc. on May 19, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biofilm, Inc.
- Inspection Date: 2026-05-19
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Biofilm, Inc., a manufacturer of Class II personal lubricant medical devices in Vista, CA, was cited for failing to submit Medical Device Reports (MDRs) within 30 days for numerous adverse events. The firm's internal records and consumer complaints indicated potential serious injuries, including UTIs, bacterial vaginosis, yeast infections, and blistering, which were not proactively reported to the FDA. This represents a significant failure in post-market surveillance and regulatory compliance.

## Related Documents

- [483 - 2023-06-15](https://www.keypedia.com/records/483/biofilm-inc/82030d7c-5d52-4457-917b-8853f1863281) — date: June 15, 2023

## Related Officers

- [Jenny L. Chisem](https://www.keypedia.com/people/jenny-l-chisem/d9c3fada-4f08-4f1a-9c6c-06a3c521534c)

Company: https://www.keypedia.com/companies/biofilm-inc/97b5de6b-0281-4eb7-afab-5a0f5dbde1f0

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6