1Aseptic processing and sterility assurance
Smoke study conducted on 6/21/2019 to determine unidirectional airflows in ISO 5 LAFW was inadequate.
Inspection Record
Southern California Compounding Pharmacy, LLC — FDA 483 Findings
Inspectors Santiago Gallardo JohnsonThe 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
The firm's cleaning and disinfecting procedure in the aseptic processing area are deficient.
3Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans, and test procedures designed to assure drug products confonn to appropriate standards of identity, strength, quality and purity.
About this record
Extracted automatically from the document US FDA published on 2019-10-21. 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.
