# FDA 483 - UBI Pharma, Inc. - October 14, 2025

Source: https://www.keypedia.com/records/483/ubi-pharma-inc/3a306b84-362f-4c3e-848b-0abc60c4621f

> FDA 483 for UBI Pharma, Inc. on October 14, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: UBI Pharma, Inc.
- Inspection Date: 2025-10-14
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: UBI Pharma Inc. was cited for significant deficiencies in its manufacturing and quality control processes for sterile injectable drug products. Issues include unqualified visual inspection equipment, inadequate control procedures for particulate matter, failures in aseptic processing, and a dysfunctional quality control unit that neglected complaint investigations and change control. These lapses resulted in the release of potentially compromised drug products to the US market.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/ubi-pharma-inc/b39cf96c-6b57-40cf-9438-9ae2289de3b8)
- [483 - 2023-06-06](https://www.keypedia.com/records/483/ubi-pharma-inc/43190848-e5f1-4e4f-9b4a-33ded6172cff)
- [483 - 2025-10-06](https://www.keypedia.com/records/483/ubi-pharma-inc/73c00ddf-619f-4e38-ac2a-66a75c35e905)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)

Company: https://www.keypedia.com/companies/ubi-pharma-inc/c7dfbd38-5fae-4a48-b959-a3abae44f320

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8