# FDA 483 - Boehringer Ingelheim Fremont, Inc. - April 04, 2017

Source: https://www.keypedia.com/records/483/boehringer-ingelheim-fremont-inc/22dda148-a183-4658-941d-070cff867701

> FDA 483 for Boehringer Ingelheim Fremont, Inc. on April 04, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Boehringer Ingelheim Fremont, Inc.
- Inspection Date: 2017-04-04
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: This FDA Form 483 report identifies significant deficiencies at Boehringer Ingelheim Fremont, Inc., a facility manufacturing drug substances and products. The observations highlight inadequate validation procedures for sterile drug products, insufficient employee training for visual inspection, and issues with laboratory controls, equipment qualification, and quality assurance. These findings indicate a moderate to severe level of non-compliance, particularly impacting product sterility, quality control, and overall manufacturing integrity.

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Company: https://www.keypedia.com/companies/boehringer-ingelheim-fremont-inc/3d7d0ca7-27cd-4223-8ade-7193417c9861

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321