# FDA 483 - USpharma Ltd - May 11, 2023

Source: https://www.keypedia.com/records/483/uspharma-ltd/5b85d918-4bc8-49f3-a559-00bb1568cc04

> FDA 483 for USpharma Ltd on May 11, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: USpharma Ltd
- Inspection Date: 2023-05-11
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: USpharma Ltd, a medical device manufacturer in Miami Lakes, FL, was inspected from May 10-11, 2023. The inspection revealed that the firm failed to submit Medical Device Reports (MDRs) within the required 30 days. This failure specifically pertained to two complaints where a marketed device may have malfunctioned and potentially caused patient injury.

## Related Documents

- [EIR - 2022-06-23](https://www.keypedia.com/records/eir/uspharma-ltd/1b7353f7-e177-4db1-8c0b-7a3719207311)
- [483 - 2022-06-23](https://www.keypedia.com/records/483/uspharma-ltd/0b39cd03-552a-4aff-89ff-d0e64c602631)

## Related Officers

- [investigator](https://www.keypedia.com/people/ronald-ifraimov/b4ce8b79-3fa2-4862-b7a4-68e14e45d87a)

Company: https://www.keypedia.com/companies/uspharma-ltd/964df153-5c44-460a-949f-69325271a2b1

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6