# FDA 483 - USpharma Ltd - June 23, 2022

Source: https://www.keypedia.com/records/483/uspharma-ltd/0b39cd03-552a-4aff-89ff-d0e64c602631

> FDA 483 for USpharma Ltd on June 23, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: USpharma Ltd
- Inspection Date: 2022-06-23
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: USpharma Ltd, a prescription and OTC drug manufacturer in Miami Lakes, FL, was cited with three observations during an FDA inspection. The observations indicate significant deficiencies in laboratory controls, including unestablished test method sensitivities, incomplete laboratory records for stability testing, and a failure to thoroughly investigate unexplained discrepancies in quality control results. These issues suggest potential risks to product quality and data integrity.

## Related Documents

- [EIR - 2022-06-23](https://www.keypedia.com/records/eir/uspharma-ltd/1b7353f7-e177-4db1-8c0b-7a3719207311)
- [483 - 2023-05-11](https://www.keypedia.com/records/483/uspharma-ltd/5b85d918-4bc8-49f3-a559-00bb1568cc04)

## Related Officers

- [Jennifer Lalama](https://www.keypedia.com/people/jennifer-lalama/5ebc4da1-62ac-4b15-89a8-e18b0606e0ff)

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