1Contamination control
Non-microbial contamination was observed in your production area.
Inspection Record
Colonia Care Pharmacy — FDA 483 Findings
Inspectors Unnee Ranjan · Jessica S EstripletThe 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
You produced highly potent diugs without providing adequate containment, segregation, cleaning of work surfaces, cleaning of utensils and cleaning of personnel to prevent cross-contamination.
3Aseptic processing and sterility assurance
The use of sporicidal agents in the ISO 5 classified aseptic processing area was inadequate and infrequent.
About this record
Extracted automatically from the document US FDA published on 2021-10-20. 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.
