1Regulatory reporting and change control
Written procedures have not been developed for the reporting to FDA of post marketing adverse drug experiences.
Inspection Record
Misemer Pharmaceutical, Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Regulatory reporting and change control
An annual report was not submitted within 60 days of the anniversary date of U.S.
3Other quality system
Not all annual periodic adverse drug experience reports have been submitted within 60 days of the anniversary date of the approval of the application.
4Other quality system
Not all quarterly periodic adverse drug experience reports have been submitted within 30 days of the close of the quarter.
About this record
Extracted automatically from the document US FDA published on 2026-07-14. 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.
