# FDA 483 - Command Medical Products Nicaragua S.A. - December 05, 2013

Source: https://www.keypedia.com/records/483/command-medical-products-nicaragua-sa/c5eb6c6e-eb07-4f48-b598-8d90a75da9c7

> FDA 483 for Command Medical Products Nicaragua S.A. on December 05, 2013. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Command Medical Products Nicaragua S.A.
- Inspection Date: 2013-12-05
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Command Medical Nicaragua S.A., a medical device manufacturer in Managua, Nicaragua, was inspected by the FDA from December 2-5, 2013. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding internal audit procedures and the validation and documentation of critical sealing processes for Tyvek pouches. These issues indicate a lack of adequate controls to ensure product quality and consistency.

## Related Officers

- [Coordinator](https://www.keypedia.com/people/wanda-j-torres/8c2c8963-2a8a-4dda-b5cf-c87e52705f45)

Company: https://www.keypedia.com/companies/command-medical-products-nicaragua-sa/a43a15ad-9fc1-471f-a34b-9e61419ba007

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