# FDA 483 - Bio-Rad Laboratories, Inc. - October 21, 2019

Source: https://www.globalkeysolutions.net/records/483/bio-rad-laboratories-inc/8cbbd2f7-b9fd-4d0c-ae12-b39199310a80

> FDA 483 for Bio-Rad Laboratories, Inc. on October 21, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Bio-Rad Laboratories, Inc.
- Inspection Date: 2019-10-21
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Bio-Rad Laboratories, Inc. in Woodinville, WA, a licensed IVD manufacturer, revealed two significant observations. The firm failed to establish adequate process control procedures, specifically lacking detailed instructions in Manufacturing Batch Records. Additionally, schedules for equipment adjustment, cleaning, and maintenance were not established, and filling machines were observed with cleanliness issues.

## Related Documents

- [483 - 2021-12-13](https://www.globalkeysolutions.net/records/483/bio-rad-laboratories-inc/23c046ed-1013-40ed-9ca9-97d618941c5c)
- [483 - 2025-01-31](https://www.globalkeysolutions.net/records/483/bio-rad-laboratories-inc/36343efa-7c4a-4197-83d5-855e16640377)

## Related Officers

- [CSO](https://www.globalkeysolutions.net/people/mihaly-s-ligmond/2904ef70-a757-49c7-9ac4-a2c07ee36001)

Company: https://www.globalkeysolutions.net/companies/bio-rad-laboratories-inc/b3fd776e-6823-4ba3-87b0-f03cf4880139

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822