# FDA 483 - Boehringer Ingelheim RCV GmbH & Co KG - November 16, 2023

Source: https://www.keypedia.com/records/483/boehringer-ingelheim-rcv-gmbh-co-kg/5b8989de-6d3a-451f-907b-7ccb9c53d1bf

> FDA 483 for Boehringer Ingelheim RCV GmbH & Co KG on November 16, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Boehringer Ingelheim RCV GmbH & Co KG
- Inspection Date: 2023-11-16
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Boehringer Ingelheim RCV GmbH & Co KG in Vienna, Austria, a drug substance manufacturer, revealed significant issues primarily related to contamination control and quality system deficiencies. The firm experienced repeated contamination events in drug substance and intermediate batches, indicating inadequate manufacturing controls. Further concerns included incomplete master production records, insufficient investigations and CAPA initiation, poor laboratory controls, inadequate analytical SOPs, and improper cleanroom qualification and material storage practices.

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Company: https://www.keypedia.com/companies/boehringer-ingelheim-rcv-gmbh-co-kg/44a0d48b-1c34-490c-87fe-ccfec769342f

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