# FDA 483 - Horizons International Corporation - February 16, 2023

Source: https://www.keypedia.com/records/483/horizons-international-corporation/312acc70-c518-49b4-a771-530031558748

> FDA 483 for Horizons International Corporation on February 16, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Horizons International Corporation
- Inspection Date: 2023-02-16
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Horizons International Corporation, a medical device manufacturer in La Valencia Heredia, Costa Rica, was inspected by the FDA from February 13-16, 2023. The inspection revealed significant deficiencies in their quality system, including failures in developing MDR procedures, controlling nonconforming products, investigating complaints, and establishing adequate corrective and preventive actions. These issues indicate a lack of robust quality management practices for their Class I and Class II medical devices.

## Related Officers

- [Investigator](https://www.keypedia.com/people/shafiq-s-ahadi/dd146b0a-ca1c-4052-8f50-4d68e14ad73f)

Company: https://www.keypedia.com/companies/horizons-international-corporation/dd8345c2-2560-40a3-9bdd-1486cfb3a510

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