# FDA 483 - Cetro America Inc. - February 01, 2024

Source: https://www.keypedia.com/records/483/cetro-america-inc/313ac8a5-1fde-487c-92e5-9c8506d70b0c

> FDA 483 for Cetro America Inc. on February 01, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cetro America Inc.
- Inspection Date: 2024-02-01
- Product Type: device
- Office Name: New England District Office
- Summary: Cetro America Inc. in Meriden, CT, was issued a Form 483 with three observations following an FDA inspection. The firm demonstrated significant deficiencies in its quality system, including the absence of written Medical Device Reporting (MDR) procedures, inadequate complaint handling processes, and insufficient control over purchased products and services from contract manufacturers. These issues highlight a fundamental lack of established and implemented procedures critical for medical device manufacturing compliance.

## Related Documents

- [483 - 2018-01-11](https://www.keypedia.com/records/483/cetro-america-inc/40797fe8-5154-4c8c-bf7e-236f3609c5ad)

## Related Officers

- [Katarzyna Plona](https://www.keypedia.com/people/katarzyna-plona/ea20d6c6-5d2d-41a0-a755-0647fb9f3250)

Company: https://www.keypedia.com/companies/cetro-america-inc/425c796a-3b5b-4618-a7e4-03649bb4ba5e

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144