# FDA 483 - Boehringer Ingelheim RCV GmbH & Co KG - November 19, 2018

Source: https://www.globalkeysolutions.net/records/483/boehringer-ingelheim-rcv-gmbh-co-kg/e25819fd-f705-497d-90d5-9e3e164ead31

> FDA 483 for Boehringer Ingelheim RCV GmbH & Co KG on November 19, 2018. 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: 2018-11-19
- Product Type: drugs
- Office Name: Division of Advertising & Promotion 
- Summary: An FDA inspection of Boehringer Ingelheim RCV GmbH & Co KG in Vienna, Austria, identified inadequate process equipment. Specifically, the firm's scraping practices introduced foreign particles into process intermediates, indicating a deficiency in maintaining equipment surfaces. This issue could compromise the quality of drug substances produced.

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## Related Officers

- [Richard Ledwidge](https://www.globalkeysolutions.net/people/richard-ledwidge/aaf4f089-8f7a-4d1f-b2e1-5f2e476a22a9)
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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-advertising-promotion/adcc8282-aca9-4610-955c-e6553c7619b0