1Aseptic processing and sterility assurance
The <Redacted B4> not always conducted for each lot of sterile drug products.
Inspection Record
San Diego Compounding Pharmacy — FDA 483 Findings
Inspectors Joey V. QuitaniaThe 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
Room air pressure differentials are not monitored during each production ofaseptically processed sterile drug products.
3Aseptic processing and sterility assurance
The firm has not demonstrated that the aseptic filling and closing operations are a dequate to produce sterile drug products.
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.
