# FDA 483 - Clavmed - October 29, 2025

Source: https://www.keypedia.com/records/483/clavmed/694e4c9f-cc8e-4b26-a476-2b29f2ef7e1e

> FDA 483 for Clavmed on October 29, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Clavmed
- Inspection Date: 2025-10-29
- Product Type: device
- Office Name: Office of Inspections and Investigations
- Summary: Clavmed, a contract manufacturer in Tuszyn, Poland, was inspected by the FDA and found to have a significant lack of established quality system procedures and instructions. This deficiency impacts numerous critical areas including quality audits, change controls, process validation, and complaint handling. The findings indicate a fundamental absence of a robust quality management system at the firm.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/maryam-tabatabaie/b792042d-e296-446d-90a9-d30c8f635506)

Company: https://www.keypedia.com/companies/clavmed/d0a7aca5-92b1-408f-a5e8-4b84f2cd35bf

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8