# FDA 483 - BASF Corporation - November 17, 2017

Source: https://www.globalkeysolutions.net/records/483/basf-corporation/bc2c0d1e-80b8-4f1c-b18d-7fce15c869a0

> FDA 483 for BASF Corporation on November 17, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BASF Corporation
- Inspection Date: 2017-11-17
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of BASF Corporation, an OTC drug manufacturer in East Setauket, NY, revealed significant deficiencies in quality control, process validation, laboratory controls, and equipment qualification. The firm failed to thoroughly investigate out-of-specification results, lacked cleaning and process validations, did not support media expiry dates, and had unqualified manufacturing equipment. These issues indicate a lack of robust quality systems for drug product manufacturing.

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## Related Officers

- [Mindy M. Chou](https://www.globalkeysolutions.net/people/mindy-m-chou/3d0e74bf-ad6b-48b5-8b72-cbb29e9c9ce5)

Company: https://www.globalkeysolutions.net/companies/basf-corporation/c1e582b1-32db-4730-a43c-5023d59a5654

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961