Findings
1Laboratory and QC controls
Subject (b)(6) was randomized into the study and dispensed investigational drug on (b)(6) , without a laboratory-confirmed (b)(4) of randomization. In fact, this subject had a (b)(4) test result on (b)(6) . In your January 6, 2023, written response to the Form FDA 483, you stated that you take full responsibility for all study-related activities conducted under your supervision. You also acknowledged that subjects should not have been enrolled in the protocol because they…
2Laboratory and QC controls
Subject (b)(6) was randomized into the study and dispensed investigational drug on (b)(6) , without a laboratory-confirmed (b)(4) of randomization.
3Laboratory and QC controls
Subject (b)(6) was randomized into the study and dispensed investigational drug on (b)(6) , without a laboratory-confirmed (b)(4) of randomization. In fact, this subject had a negative (b)(4) test result on (b)(6) .
4Laboratory and QC controls
Subject (b)(6) was randomized into the study and dispensed investigational drug on (b)(6) , without a laboratory-confirmed (b)(4) of randomization. In fact, this subject had a (b)(4) test result on (b)(6) .
About this record
Extracted automatically from the document US FDA published on 2023-11-21. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
