# FDA 483 - Merck, Inc. - June 18, 2026

Source: https://www.keypedia.com/records/483/merck-inc/03fce7a9-907d-49c9-a3c3-4538f75f810b

> FDA 483 for Merck, Inc. on June 18, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Merck, Inc.
- Inspection Date: 2026-06-18
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Schering Plough Corp. in Kenilworth, NJ, revealed significant deficiencies in their pharmaceutical manufacturing operations. Observations included inadequate qualification of a process control computer, a lack of investigation into product color changes, and insufficient investigations into microbial contamination in the water system. These issues indicate a failure to maintain adequate quality control and validation practices.

## Related Officers

- [company_representative](https://www.keypedia.com/people/john-kozlowski/48aa14aa-ed18-409a-987f-4e6345140dc5)

Company: https://www.keypedia.com/companies/merck-inc/653c4599-f3e9-4a8f-bf86-eb7cb524b296

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248