1Aseptic processing and sterility assurance
Equipment, materials, and/or supplies are not disinfected prior to entering the aseptic processing areas.
Inspection Record
Carepoint Healthcare, LLC dba Carepoint Pharmacy — FDA 483 Findings
Inspectors Debra I. Love · Bryan L. McGuckinThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Media Fills are performed in a manner that does not closely simulate production operations at the firm, incorporating as appropriate, worst-case activities and conditions commonly encountered during production.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to ensure aseptic conditions.
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.
