# FDA 483 - Bayer HealthCare, LLC - November 13, 2019

Source: https://www.globalkeysolutions.net/records/483/bayer-healthcare-llc/099cd172-5e0d-4281-8a42-0607754a1152

> FDA 483 for Bayer HealthCare, LLC on November 13, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bayer HealthCare, LLC
- Inspection Date: 2019-11-13
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Bayer Healthcare LLC in Berkeley, CA, identified critical deficiencies in quality control and manufacturing processes. These issues included the mislabeling of drug products, leading to a recall and adverse events, as well as inadequate investigation of discrepancies and failures in product testing for foreign materials. The findings highlight a need for improved procedural controls, robust testing methods, and effective document management to ensure product quality and patient safety.

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## Related Officers

- [Zuben E. Sauna, Research Biologist](https://www.globalkeysolutions.net/people/zuben-e-sauna-research-biologist/6fe72300-e3c0-4dc7-9270-1a616888aedd)
- [Daniel Lagasse](https://www.globalkeysolutions.net/people/daniel-lagasse/7da2b202-7dda-4b86-bdd7-79f89414a079)
- [Linda Thai, Investigator](https://www.globalkeysolutions.net/people/linda-thai-investigator/9c738d99-071d-4ca5-9988-10b646171e72)
- [Prabhu P. Raju, Investigator](https://www.globalkeysolutions.net/people/prabhu-p-raju-investigator/33d0f9c9-4868-4f5f-a771-69bc6a0527e8)

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