# FDA 483 - MEDISIZE CZ - April 03, 2023

Source: https://www.globalkeysolutions.net/records/483/medisize-cz/40723a96-c308-4fe1-b9c0-708a8628bebd

> FDA 483 for MEDISIZE CZ on April 03, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MEDISIZE CZ
- Inspection Date: 2023-04-03
- Product Type: device
- Office Name: International Compliance Team
- Summary: An FDA inspection of Medisize CZ in Trhove Sviny, Czech Republic, identified four observations related to its device manufacturing operations. The firm was cited for inadequate procedures concerning equipment calibration, environmental controls, and the documentation of corrective and preventive actions. Additionally, deficiencies were noted in the established procedures for handling customer complaints.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/stephen-d-eich/a932e816-cbe3-4f1c-84e7-8a81cc8b529e)

Company: https://www.globalkeysolutions.net/companies/medisize-cz/b560a3b2-7cd2-4847-8f65-09ec2924c753

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