1Material and supplier control
Eaoh lot o f a component liable to objectionable microbi olog ical contamination is defic iently subjected to micro bio logica l tests before use.
Inspection Record
Health Innovations Pharmacy, Inc — FDA 483 Findings
Inspectors Joseph F. OwensThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system fo r cleaning and disinfecting the equipment to produce aseptiq conditions.
3Aseptic processing and sterility assurance
Procedu res designed to prevent mic ro biological contami nation ofdrug products purporting to he sterile do not include validation o f the sterili2ation process.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
5Aseptic processing and sterility assurance
Each batch ofd rug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.
6Process validation
Time lim its are not established when app ropriate for the completion ofeach production phase to assure the quality of the ¢ rug product.
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.
