# FDA 483 - Covidien - April 28, 2022

Source: https://www.keypedia.com/records/483/covidien/12fd16f6-4daa-44f4-ad0e-af1cf5dc12b6

> FDA 483 for Covidien on April 28, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Covidien
- Inspection Date: 2022-04-28
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Covidien Davis & Geck Caribe LCD & Medtronic Dominicana (Manufactura) S.A. in San Isidro, Dominican Republic, revealed significant quality system deficiencies. The firm failed to adequately validate the mixing process for radiopaque markers used in medical devices and did not establish or fully implement adequate procedures for acceptance activities, including incoming material verification and in-process acceptance. These issues indicate a lack of control over critical manufacturing processes and material quality.

## Related Officers

- [Joshua J. Silvestri](https://www.keypedia.com/people/joshua-j-silvestri/433e29b3-ce5f-44d2-9984-7a6cb61e1824)

Company: https://www.keypedia.com/companies/covidien/b19dc04e-0d0e-489f-94c0-d6d406d65a22

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd