1Contamination control
Personnel did not disinfect to prevent contamination.
Inspection Record
New Vitalis Pharmacy LLC dba New Vitalis Pharmacy — FDA 483 Findings
Inspectors Lauren N Howard · Carl A HuffmanThe 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
Non-microbial contamination was observed in your production area.
3Equipment and facility
Vermin was observed in an area immediately adjacent to your production area.
4Contamination control
You produced hazardous drugs without providing adequate cleaning of utensils to prevent cross-contamination.
5Training and personnel
Personnel donned gowning apparel improperly, in a way that may have caused the gowning apparel to become contaminated.
6Aseptic processing and sterility assurance
Personnel conducted aseptic manipulations in an area that blocked the movement of first pass air around an open unit, either before or after it was filled with sterile product.
7Equipment and facility
HEPA filters were not sealed around each perimeter to the support frame.
About this record
Extracted automatically from the document US FDA published on 2022-03-09. 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.
