# FDA 483 - Merck & Cie - November 02, 2018

Source: https://www.keypedia.com/records/483/merck-cie/4dc6a2a1-e793-4f85-945b-f6bb9c135cac

> FDA 483 for Merck & Cie on November 02, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Merck & Cie
- Inspection Date: 2018-11-02
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: During an inspection of Merck & Cie, an API manufacturer in Schaffhausen, Switzerland, the FDA observed significant deficiencies in the control of computer and laboratory systems. Specifically, laboratory personnel were assigned administrator roles allowing data manipulation, and the chromatographic software lacked essential audit trail capabilities. These findings indicate a lack of appropriate controls over electronic raw data and potential data integrity issues.

## Related Documents

- [483 - 2018-11-02](https://www.keypedia.com/records/483/merck-cie/03b23b60-8023-49d3-b084-d0dddd84b4d2)

## Related Officers

- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.keypedia.com/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)

Company: https://www.keypedia.com/companies/merck-cie/7a318238-e1c9-4962-94fe-53359569a739

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