# FDA 483 - Boehringer Ingelheim Fremont - May 16, 2024

Source: https://www.globalkeysolutions.net/records/483/boehringer-ingelheim-fremont/ad0a448d-1cc1-4972-abde-e9d4a9f6b3c0

> FDA 483 for Boehringer Ingelheim Fremont on May 16, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Boehringer Ingelheim Fremont
- Inspection Date: 2024-05-16
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: The FDA inspected Boehringer Ingelheim Fremont, a drug substance manufacturer, from May 8-16, 2024. The inspection revealed significant deficiencies across quality unit procedures, equipment control and qualification, facility maintenance, contamination prevention, manufacturing process validation, laboratory procedures, and adherence to BLA parameters. These issues indicate a broad lack of control over critical aspects of drug substance manufacturing, posing a moderate to severe risk to product quality and patient safety.

## Related Officers

- [Chandan Thomas](https://www.globalkeysolutions.net/people/chandan-thomas/8ebd1a5a-9d22-4f60-a253-65a7ae181386)
- [Yun Wu](https://www.globalkeysolutions.net/people/yun-wu/ae378596-ea82-4254-b169-b592878202eb)
- [Philip Angart](https://www.globalkeysolutions.net/people/philip-angart/356242cd-f6f5-4df6-b795-75e0d24b63ef)
- [Abigail Marella](https://www.globalkeysolutions.net/people/abigail-marella/abb1ee02-7915-4a14-b41d-3473a5a9b946)
- [Lindsey Brown](https://www.globalkeysolutions.net/people/lindsey-brown/ff47f714-146f-474e-a6b8-2cf14c67dd4f)

Company: https://www.globalkeysolutions.net/companies/boehringer-ingelheim-fremont/04e6c10f-cf56-4a54-9986-4ce71fb4e43b

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd