# FDA 483 - UBI Pharma, Inc. - October 06, 2025

Source: https://www.keypedia.com/records/483/ubi-pharma-inc/73c00ddf-619f-4e38-ac2a-66a75c35e905

> FDA 483 for UBI Pharma, Inc. on October 06, 2025. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: UBI Pharma, Inc.
- Inspection Date: 2025-10-06
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: UBI Pharma Inc., a drug product manufacturer in Hsinchu, Taiwan, received an FDA Form 483 following an inspection from October 6 to October 14, 2025. The inspection revealed several critical deviations from Current Good Manufacturing Practices (CGMP), particularly affecting quality control and sterility assurance for injectable drug products. Key observations included that equipment used for visual inspection of injectable vials was not appropriately designed or adequately qualified, with defect samples lacking proper documentation and control. Control procedures for monitoring manufacturing processes and ensuring product quality were found deficient. This encompassed inadequate Acceptance Quality Limit (AQL) testing protocols, poorly designed and managed visual inspection test kits, and inconsistent qualification of visual inspectors. Additionally, multiple product complaints were inadequately investigated without determining root causes. Serious concerns were also raised regarding procedures to prevent microbiological contamination of sterile products; specifically, laminar flow hood performance qualification protocols were deficient, and operator interventions compromised critical sterile areas by blocking airflow over open vials. UBI Pharma Inc. is required to implement comprehensive corrective and preventive actions to address these observations and ensure compliance with CGMP regulations, safeguarding drug product safety and efficacy.

## 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 - 2025-10-14](https://www.keypedia.com/records/483/ubi-pharma-inc/3a306b84-362f-4c3e-848b-0abc60c4621f)

## 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/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c