1Other quality system
Written procedures are not followed for the identification, handling and approval of closures.
Inspection Record
Stokes Pharmacy — 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
2Equipment and facility
Equipment used in the manufacture, processing, packing or holding of drug products· is not of appropriate design to facilitate operations for its intended use arid cleaning and maintenance.
3Complaint and recall handling
Written procedures describing the; handling of all written and oral complaints do not include provisions for review to determine whether the complaint represents a serious and unexpected adverse drug experience which is required to be reported to the Food and Drug Administration .
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.
