Findings
1Deviation, CAPA, and investigation
You failed to ensure that an investigation was conducted according to the signed investigator statement, the investigational plan, and applicable regulations. 21 CFR § 312.60. The protocols for studies (b)(4) provide for exclusion of subjects based on specific criteria, including tests for (b)(4) panels. These protocols also specified procedures for recording and reporting Adverse Events (AEs). A. As a Sponsor-Investigator you failed to adhere to requirements specified in…
2Other quality system
You failed to retain records and reports as required for 2 years after a marketing application is approved for the drug; or, if an application is not approved for the drug, until 2 years after shipment and delivery of the drug for investigational use is discontinued and FDA has been so notified 21 CFR § 312.57(c). For example, at the time of the inspection in April 2023, no marketing application for the drug being studied under IND (b)(4) had been approved and shipment and…
3Deviation, CAPA, and investigation
You failed to ensure proper monitoring of the investigation(s) and to ensure that the investigation(s) were conducted in accordance with the general investigational plan and protocols contained in the IND. 21 CFR § 312.50. For example, an independent medical monitor was to review all AEs for all subjects according to the protocols for studies (b)(4) . Per the protocols “[a]ll safety/adverse event data will be sent to the Independent Medical Monitor for review. All…
About this record
Extracted automatically from the document US FDA published on 2025-06-03. 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.
