# FDA EIR - Merck KGaA - September 08, 2017

Source: https://www.keypedia.com/records/eir/merck-kgaa/93981bf5-fbca-4d08-9ce7-5aa69a235568

> FDA EIR for Merck KGaA on September 08, 2017. Product: veterinary. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Merck KGaA
- Inspection Date: 2017-09-08
- Product Type: veterinary
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of Merck KGaA, an active pharmaceutical ingredient (API) and excipient manufacturer located in Darmstadt, Germany, took place from September 4 to September 8, 2017. The inspection, conducted under cGMP regulations and guided by CPGMs for API processes and pre-approval inspections, assessed the company's Quality, Production, Facilities and Equipment, Laboratory, and Material systems. During the inspection, two verbal observations were made: the process for a specific API was not validated to current standards, and the cleaning validation for another manufacturing process was deemed inadequate. However, no formal FDA-483 Inspectional Observations form was issued to Merck KGaA. As a result, the inspection was classified as "No Action Indicated" (NAI) for Good Manufacturing Practices (GMP), with a recommendation for approval of a specified drug master file. Given the NAI classification and the absence of an FDA-483, no formal regulatory actions were explicitly required from the company following this inspection. The site's registration was current.

## Related Documents

- [483 - 2009-07-02](https://www.keypedia.com/records/483/merck-kgaa/58f91917-eff3-4b66-9c3b-de4e723183eb)

## Related Officers

- [investigator](https://www.keypedia.com/people/meyer-j-slobotsky/625395f6-b112-4da5-9987-d9be0f19315e)
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Company: https://www.keypedia.com/companies/merck-kgaa/b5abb295-f221-4b66-9a49-d564f70c388b

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64