1Aseptic processing and sterility assurance
Disinfecting agents and cleaning pads or wipes used in the ISO 5 aseptic processing areas are not sterile.
Inspection Record
Stanley Specialty Pharmacy Compounding and Wellness Center — FDA 483 Findings
Inspectors Seneca Toms · Bonita ChesterThe 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
Environmental monitoring was not performed in your aseptic processing areas.
3Other quality system
There is insufficient data to support the percentage of preservative used to ensure anti-microbial effectiveness in multi-dose stock solutions which are used to formulate finished 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.
