1Contamination control
Highly potent drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination.
Inspection Record
Montana Compounding Pharmacy P.C. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
Non-pharmaceutical grade components are used in the formulation of non-sterile drug products.
3Contamination control
Non-microbial contamination was observed in your production area.
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.
