1Contamination control
Your firm produced hazardous drugs without providing adequate containment, segregation, cleaning of work surfaces, and cleaning of utensils to prevent cross-contamination.
Inspection Record
Maag Prescription Center LLC — FDA 483 Findings
Inspectors Tracy K. LiThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Contamination control
Your firm lacks proper control to prevent contamination of drug products during production.
3Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
4Contamination control
Mixing tools used in the production of drug products is not ofappropriate design to facilitate cleaning and to prevent microbiological contamination of drugs.
About this record
Extracted automatically from the document US FDA published on 2019-04-30. 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.
