# FDA 483 - Diasorin Deutschland GmbH - May 30, 2014

Source: https://www.keypedia.com/records/483/diasorin-deutschland-gmbh/350229be-449a-47de-b790-9949bb152493

> FDA 483 for Diasorin Deutschland GmbH on May 30, 2014. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Diasorin Deutschland GmbH
- Inspection Date: 2014-05-30
- Product Type: other
- Office Name: Division of Advertising & Promotion 
- Summary: Diasorin Deutschland GmbH in Dietzenbach, Germany, was inspected by the FDA from May 26-30, 2014, resulting in a Form FDA-483 with two observations. The inspection revealed deficiencies in establishing adequate procedures for environmental control during manufacturing and in validating software used in production.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/maryam-tabatabaie/b792042d-e296-446d-90a9-d30c8f635506)

Company: https://www.keypedia.com/companies/diasorin-deutschland-gmbh/a568a5e5-2123-4e66-9b8a-70df2899868e

Office: https://www.keypedia.com/offices/division-of-advertising-promotion/adcc8282-aca9-4610-955c-e6553c7619b0