1Other quality system
Procedures designed to prevent insanitary conditions are not established or followed.
Inspection Record
Vital Care of Dickson, LLC. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Disinfecting agents used in the ISO 5 classified aseptic processing areas were not sterile.
3Aseptic processing and sterility assurance
Failure to conduct media fill studies that closely simulate aseptic processing operations under the worst-case, most-challenging and stressful conditions.
4Aseptic processing and sterility assurance
Pressure differentiaJs are not monitored in areas where aseptic processing occurs.
About this record
Extracted automatically from the document US FDA published on 2020-11-20. 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.
