# FDA 483 - Shanghai Ambiopharm Inc. - May 22, 2026

Source: https://www.keypedia.com/records/483/shanghai-ambiopharm-inc/e7b9fe4d-7205-46e2-aa43-cb2362aea1e2

> FDA 483 for Shanghai Ambiopharm Inc. on May 22, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shanghai Ambiopharm Inc.
- Inspection Date: 2026-05-22
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Shanghai AmbioPharm, Inc., a drug manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included a lack of written quality control procedures and quality agreements with third-party testers, unqualified and poorly managed manufacturing equipment, and incomplete master production and batch records. These issues indicate a systemic failure in maintaining adequate control over manufacturing processes and quality assurance.

## Related Officers

- [Supervisory Consumer Safety Officer, China Office](https://www.keypedia.com/people/marcus-a-ray/d394d757-5569-4697-bec1-c24113e29d6f)

Company: https://www.keypedia.com/companies/shanghai-ambiopharm-inc/f65fc19c-d2f1-4161-b4c6-fc5d82566ea0

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3