# FDA 483 - Bayer Healthcare, LLC - January 06, 2011

Source: https://www.globalkeysolutions.net/records/483/bayer-healthcare-llc/5fc13411-a36c-481c-9f9a-cba46f0d4320

> FDA 483 for Bayer Healthcare, LLC on January 06, 2011. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bayer Healthcare, LLC
- Inspection Date: 2011-01-06
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Conceptus, Inc. in Mountain View, CA, a medical device manufacturer, was cited for significant deficiencies in its quality system. The inspection revealed failures to submit Medical Device Reports (MDRs) for serious injuries and device malfunctions, incomplete risk analysis for its Essure product, and inadequate documentation of corrective and preventive actions. These issues indicate a systemic breakdown in post-market surveillance and quality control processes.

## Related Documents

- [EIR - 2002-07-11](https://www.globalkeysolutions.net/records/eir/bayer-healthcare-llc/c54c44f7-2238-477e-812e-bea4965bed83)
- [EIR - 2003-07-07](https://www.globalkeysolutions.net/records/eir/bayer-healthcare-llc/27d00e56-058e-4c87-aea2-a76101c17ac8)
- [EIR - 2008-07-11](https://www.globalkeysolutions.net/records/eir/bayer-healthcare-llc/c6a073ac-c0b7-4e07-acce-fc295a360f00)
- [EIR - 2013-06-26](https://www.globalkeysolutions.net/records/eir/bayer-healthcare-llc/fa85caa9-dd83-4a0d-8b6b-1831994284b9)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/timothy-c-grome/1db21819-ef0e-4bc1-85c6-bf160c7aed8f)

Company: https://www.globalkeysolutions.net/companies/bayer-healthcare-llc/2f70f75d-bc88-4bdf-b93f-5d8ad0f1f80c

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