# FDA 483 - Abbisko Therapeutics Co., Ltd. - March 20, 2026

Source: https://www.keypedia.com/records/483/abbisko-therapeutics-co-ltd/4f6bc9f6-e302-4a89-8033-c0e266f95ffc

> FDA 483 for Abbisko Therapeutics Co., Ltd. on March 20, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Abbisko Therapeutics Co., Ltd.
- Inspection Date: 2026-03-20
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: Between March 9 and March 20, 2026, the FDA conducted an inspection of Abbisko Therapeutics Co., Ltd., a commercial sponsor located in Shanghai, China. The inspection revealed a significant failure in the firm"s oversight of clinical study protocols. Specifically, the company failed to adequately supervise a third-party vendor responsible for managing serious adverse event reporting. This lack of oversight resulted in a data integrity breach where five staff members, who were required to remain unaware of specific treatment assignments to ensure study objectivity, were granted unauthorized access to unblinded safety information for over seven months. Although two employees accessed these sensitive reports, they did not report the security lapse internally. Abbisko remained unaware of the full extent of this unauthorized access for nearly two years and did not initiate a formal corrective action plan until January 2026. These findings were documented under the authority of the Federal Food, Drug, and Cosmetic Act. The company is now required to address these deficiencies in trial management and data security, and they have the opportunity to submit a formal response outlining their planned corrective measures to the FDA.

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Company: https://www.keypedia.com/companies/abbisko-therapeutics-co-ltd/e537f548-98e3-4a60-a6f6-be0b736c0422

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa