Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.
Inspection Record
L. Perrigo Co — FDA 483 Findings
Inspectors Martha Sullivan MyrickThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
Employees are not given training in written procedures required by current good manufacturing practice regulations.
Complaint records are deficient in that they do not include the findings of the investigation.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
