# FDA 483 - Biofilm, Inc. - June 15, 2023

Source: https://www.globalkeysolutions.net/records/483/biofilm-inc/82030d7c-5d52-4457-917b-8853f1863281

> FDA 483 for Biofilm, Inc. on June 15, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biofilm, Inc.
- Inspection Date: 2023-06-15
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of BioFilm, Inc. in Vista, CA, a manufacturer, identified two observations. The firm failed to adequately establish procedures for the review and disposition of nonconforming products and did not maintain proper records. Additionally, schedules for equipment maintenance, including logs and reviews, were not adequately established.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

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

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