# FDA 483 - Kaysersberg Pharmaceuticals SAS - July 19, 2016

Source: https://www.keypedia.com/records/483/kaysersberg-pharmaceuticals-sas/0c0bf131-b1c2-42bc-9baa-13273ff535d0

> FDA 483 for Kaysersberg Pharmaceuticals SAS on July 19, 2016. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Kaysersberg Pharmaceuticals SAS
- Inspection Date: 2016-07-19
- Product Type: drugs
- Office Name: Division of Blood Components and Devices
- Summary: Kaysersberg Pharmaceuticals SAS, a drug manufacturer in Kaysersberg, France, was cited for multiple deficiencies during an FDA inspection. Key issues include inadequate investigations into discrepancies, insufficient environmental monitoring in aseptic areas, and failures in sanitation, cleaning, calibration, and process control procedures. The observations indicate a lack of robust quality systems and process validation.

## Related Documents

- [483 - 2023-07-07](https://www.keypedia.com/records/483/kaysersberg-pharmaceuticals-sas/7ea9666e-82c7-40b1-a9c0-03ebefaa7e8e)

## Related Officers

- [Investigator](https://www.keypedia.com/people/michael-a-charles/f83241f0-ae3b-4535-ac03-e790bbf666ca)

Company: https://www.keypedia.com/companies/kaysersberg-pharmaceuticals-sas/4f0bba88-dadd-49db-8e17-08165e705377

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917