# FDA 483 - Roche Diagnostics GmbH - Unknown Date

Source: https://www.keypedia.com/records/483/roche-diagnostics-gmbh/06ecc49c-2224-462e-b964-933d319f0b17

> FDA 483 for Roche Diagnostics GmbH on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Roche Diagnostics GmbH
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Roche Diagnostics GmbH, a drug substance manufacturer in Penzberg, Germany, was cited for significant deficiencies during an FDA inspection. Observations included inadequate equipment validation, specifically for freezers lacking temperature mapping, and widespread issues with document control. These document control problems encompassed noncontemporary documentation, backdating, overwriting, insufficient GMP oversight, and improper handling of critical reagents.

## Related Documents

- [483 - 2025-08-01](https://www.keypedia.com/records/483/roche-diagnostics-gmbh/bebca28c-5fa2-42b5-a72f-fb536d469d06)

## Related Officers

- [Kyunghun Park](https://www.keypedia.com/people/kyunghun-park/c1aac046-d200-42bf-b91d-0a89edc7e375)
- [Shadia Zaman](https://www.keypedia.com/people/shadia-zaman/c534a993-7a9b-401e-bfe7-b209a916cf6e)
- [Investigator](https://www.keypedia.com/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)

Company: https://www.keypedia.com/companies/roche-diagnostics-gmbh/a09aff2c-624a-48aa-b33e-fae16aa146f8

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd