# FDA 483 - Merck KGaA - July 02, 2009

Source: https://www.keypedia.com/records/483/merck-kgaa/58f91917-eff3-4b66-9c3b-de4e723183eb

> FDA 483 for Merck KGaA on July 02, 2009. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Merck KGaA
- Inspection Date: 2009-07-02
- Product Type: device
- Office Name: Center for Veterinary Medicine
- Summary: An FDA inspection of Merck KGaA, a medical device manufacturer in Darmstadt, Germany, revealed significant deficiencies in their quality system. Observations included failures to properly document nonconforming products, incomplete employee training records, and illegible quality processing records. These issues indicate a lack of adherence to established procedures and good documentation practices.

## Related Officers

- [investigator](https://www.keypedia.com/people/evelyn-taha/52095559-e6cc-447e-9f96-b235f52f741a)

Company: https://www.keypedia.com/companies/merck-kgaa/b5abb295-f221-4b66-9a49-d564f70c388b

Office: https://www.keypedia.com/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4