# FDA 483 - Dottikon Exclusive Synthesis AG - Unknown Date

Source: https://www.keypedia.com/records/483/dottikon-exclusive-synthesis-ag/3ce85b82-9182-42c0-9f5f-fc4017e60dd5

> FDA 483 for Dottikon Exclusive Synthesis AG on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dottikon Exclusive Synthesis AG
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: During an inspection from December 12-16, 2022, the FDA observed Dottikon Exclusive Synthesis AG, an intermediate and API manufacturer in Dottikon, Switzerland, failed to follow its written procedures. Specifically, the firm did not inform Quality Management about overdue scheduled maintenance for 24 vessels and failed to properly sample and analyze a critical material used in manufacturing processes. These deficiencies indicate a lack of adherence to established quality control protocols.

## Related Officers

- [Investigator ](https://www.keypedia.com/people/nicole-e-knowlton/8e65400f-249f-45fe-96fc-cb00fec6ae39)

Company: https://www.keypedia.com/companies/dottikon-exclusive-synthesis-ag/db7bdf8b-bd88-416f-94f2-62f946e90074

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1