# FDA 483 - Loba Feinchemie GmbH - November 03, 2025

Source: https://www.globalkeysolutions.net/records/483/loba-feinchemie-gmbh/e4d6786f-ee91-4c59-8f82-2dd5ba6f7ecd

> FDA 483 for Loba Feinchemie GmbH on November 03, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Loba Feinchemie GmbH
- Inspection Date: 2025-11-03
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Loba biotech GmbH, a drug substance manufacturer in Fischamend, Austria, was cited with seven observations during an FDA inspection. The inspection revealed significant deficiencies across manufacturing processes, quality systems, facility maintenance, and personnel training, indicating a lack of adequate control and oversight. Key issues include inadequate batch record documentation, unresolved aberrant conditions, deficient validations, and poor SOPs and deviation management.

## Related Officers

- [Neha Gupta](https://www.globalkeysolutions.net/people/neha-gupta/8e40a648-08db-4790-a9f2-0abb35feea20)
- [Arulvathani P. Arudchandran](https://www.globalkeysolutions.net/people/arulvathani-p-arudchandran/5ccc2b3e-6294-494f-a6ca-337a44eeb61e)
- [Senior Regulatory Specialist](https://www.globalkeysolutions.net/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)

Company: https://www.globalkeysolutions.net/companies/loba-feinchemie-gmbh/93a4c987-38d4-4552-a112-08159d4b61f5

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