Findings
1Other quality system
Subject (b)(6) was enrolled into Protocol (b)(4) on (b)(6) , and was subsequently enrolled in Protocol (b)(4) on (b)(6) . However, this subject was enrolled in Protocol (b)(4) on (b)(6) , the same day on which the subject was enrolled in Protocol (b)(4) ; and the subject remained in Protocol (b)(4) through (b)(6) . In your November 24, 2021, written response to the Form FDA 483, you acknowledged this observation. You explained that this subject population has rare and…
2Other quality system
Subject (b)(6) was enrolled into Protocol (b)(4) on (b)(6) . However, this subject was already enrolled and participating in Protocol (b)(4) from (b)(6) , through (b)(6) .
3Other quality system
Subject (b)(6) was enrolled into Protocol (b)(4) on (b)(6) , and was subsequently enrolled in Protocol (b)(4) on (b)(6) . However, this subject was already enrolled and participating in Protocol (b)(4) from (b)(6) , through (b)(6) .
About this record
Extracted automatically from the document US FDA published on 2022-04-19. 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.
