# FDA 483 - BIOTECH EUROPE MEDITECH Inc. Ltd - April 14, 2022

Source: https://www.keypedia.com/records/483/biotech-europe-meditech-inc-ltd/48d0e8c1-5865-4118-92f4-af11ee01489c

> FDA 483 for BIOTECH EUROPE MEDITECH Inc. Ltd on April 14, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BIOTECH EUROPE MEDITECH Inc. Ltd
- Inspection Date: 2022-04-14
- Product Type: device
- Office Name: International Compliance Team
- Summary: BIOTECH EUROPE MEDITECH Inc. Ltd, a contract manufacturer in Roscommon, Ireland, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included inadequate documentation of corrective and preventive actions, unvalidated processes, uncontrolled production processes related to water system monitoring, and a lack of auditor independence in internal quality audits. These issues indicate a failure to ensure device conformity to specifications and proper quality management.

## Related Officers

- [Esteban Beltran](https://www.keypedia.com/people/esteban-beltran/9a9bf6b2-ecdf-494c-82f4-5ef5932d629a)

Company: https://www.keypedia.com/companies/biotech-europe-meditech-inc-ltd/67ada13e-be93-4ee6-b25f-0f0d650bdbca

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321