# FDA 483 - Bayer HealthCare, LLC - August 26, 2022

Source: https://www.globalkeysolutions.net/records/483/bayer-healthcare-llc/a5797823-8e9f-4a6d-8cec-13b151299758

> FDA 483 for Bayer HealthCare, LLC on August 26, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bayer HealthCare, LLC
- Inspection Date: 2022-08-26
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Bayer HealthCare, LLC in Berkeley, CA, a sterile drug manufacturer, identified three significant issues. The firm failed to follow written procedures for equipment cleaning, inadequately documented deviations from production processes, and lacked proper controls for protective apparel. These observations indicate potential risks to product quality and sterility.

## Related Documents

- [483 - 2019-11-13](https://www.globalkeysolutions.net/records/483/bayer-healthcare-llc/099cd172-5e0d-4281-8a42-0607754a1152)

## Related Officers

- [Consumer Safety Officer (Inspector)](https://www.globalkeysolutions.net/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)

Company: https://www.globalkeysolutions.net/companies/bayer-healthcare-llc/85a8c3f6-4673-46e2-8120-d930b943ac0a

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b