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

Source: https://www.keypedia.com/records/483/loba-feinchemie-gmbh/a3257a39-6d58-4758-b0ca-60a0291be7fb

> 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: Office of Medical Device and Radiological Health Operations
- Summary: Loba biotech GmbH, a drug substance manufacturer in Fischamend, Austria, received a Form 483 with seven observations. The inspection revealed significant deficiencies across manufacturing processes, quality systems, facility maintenance, and personnel training. Key issues include inadequate batch records, deficient validations, poor CAPA implementation, and a lack of robust standard operating procedures and quality oversight.

## Related Documents

- [483 - 2025-11-03](https://www.keypedia.com/records/483/loba-feinchemie-gmbh/e4d6786f-ee91-4c59-8f82-2dd5ba6f7ecd)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4