# FDA 483 - Boehringer Ingelheim RCV GmbH & Co KG - December 05, 2023

Source: https://www.globalkeysolutions.net/records/483/boehringer-ingelheim-rcv-gmbh-co-kg/060b49d8-c11a-4a49-b649-a1e4f4140363

> FDA 483 for Boehringer Ingelheim RCV GmbH & Co KG on December 05, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Boehringer Ingelheim RCV GmbH & Co KG
- Inspection Date: 2023-12-05
- Product Type: biologics
- 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 manufacturer of drug substances, identified two significant observations. The firm's Standard Operating Procedures for critical shipping steps were found to be inadequate, lacking details on loading duration and container activation. Additionally, equipment preventive maintenance was deemed insufficient, resulting in frequent malfunctions and seal leaks on final container bottle head tubing for several drug substance batches.

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## Related Officers

- [Tate Armin](https://www.globalkeysolutions.net/people/tate-armin/8f0610fe-eeec-4ba2-9164-06b5b2a1f0f6)
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Company: https://www.globalkeysolutions.net/companies/boehringer-ingelheim-rcv-gmbh-co-kg/44a0d48b-1c34-490c-87fe-ccfec769342f

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