1Environmental monitoring
Your firm does not perform environmental monitoring for microorganisms.
Inspection Record
Vital Rx, Inc. dba Atlantic Pharmacy and Compounding — FDA 483 Findings
Inspectors Joanne E. KingThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Hazardous and highly potent drugs were prepared and handled without providing adequate cleaning of work surfaces and reusable equipment such as spateulas, beakers, and <Redac te d B4> jar s to prevent cross-contamination.
3Aseptic processing and sterility assurance
Your firm failed to perform adequate media fill studies in that they did not closely simulate aseptic operations incorporating as appropiate, worst-case activities and conditions that provide a challenge to aseptic operations.
4Other quality system
You do not have a sporicidal agent for cleaning your ISO 5 laminar flow hood
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.
