1Aseptic processing and sterility assurance
On 10/17/17, an operator was observed sanitizing his gloved hands with non-sterilc(b) (4) and then resuming aseptic processing in the ISO 5 area.
Inspection Record
Prescription Labs, Inc. dba Greenpark Compounding Pharmacy — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
The wipes used for disinfecting the interior of the ISO 5 hood are not sterile.
3Validation and qualification
The ISO 5 classified areas were not certified under dynamic conditions.
4Aseptic processing and sterility assurance
On l 0/17I17, an operator engaged in aseptic processing was observed with his upper torso inside the ISO 5 area with partially exposed skin while wearing a non-sterile mask, goggles, and hairnet.
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.
