# FDA 483 - Marin Biologic Laboratories, Inc - April 28, 2023

Source: https://www.globalkeysolutions.net/records/483/marin-biologic-laboratories-inc/84b871b2-d40d-461e-960b-aaad3a988663

> FDA 483 for Marin Biologic Laboratories, Inc on April 28, 2023. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Marin Biologic Laboratories, Inc
- Inspection Date: 2023-04-28
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Marin Biologic Laboratories, Inc. in Novato, CA, a contract testing laboratory, was cited with two observations during an FDA inspection. The firm failed to thoroughly investigate a batch failure, specifically lacking a root cause analysis for failed testing results. Additionally, their written procedures for cleaning and maintenance did not include essential preventative maintenance schedules for equipment.

## Related Officers

- [Public Affairs Specialist](https://www.globalkeysolutions.net/people/joey-v-quitania/faae874f-94ea-4b63-89d1-649e60726f6f)

Company: https://www.globalkeysolutions.net/companies/marin-biologic-laboratories-inc/ee434382-4b32-4ee9-b409-13aff0a8ccf8

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