1Complaint and recall handling
Procedures describing the handling of all written and oral complaints regarding a drug product are not established and followed.
Inspection Record
Stokes Healthcare Inc. dba Epicur Pharma — FDA 483 Findings
Inspectors Russell J GlapionThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
Deviations from written production and process control procedures are not justified.
3Process validation
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
4Process validation
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
About this record
Extracted automatically from the document US FDA published on 2020-12-22. 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.
