1Other quality system
You produced highly potent drugs without providing adequate cleaning of utensils to prevent cross contarnination.
Inspection Record
American Pharmacy of Illinois, Inc. dba Alwan Pharmacy and Compounding Center — FDA 483 Findings
Inspectors Debra I LoveThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
You used a non-pharmaceutical grade component in the formulation of a drug product.
3Aseptic processing and sterility assurance
Materials or supplies were not disinfected prior to entering the aseptic· processing areas.
4Equipment and facility
Your facility design allowed the influx ofpoor quality air into a higher classified area.
5Aseptic processing and sterility assurance
Non-sterilized and Non-depyrogenated equipment was used in sterile drug production.
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.
