1Contamination control
Your firm produced drugs while construction was underway in an adjacent area without adequate controls to prevent contamination of the production environment and product.
Inspection Record
VA New Jersey Health Care System — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Personnel touched equipment or other surface located outside the ISO 5 classified aseptic processing area with gloved hands and then engaged in aseptic processing without changing or sanitizing gloves.
3Aseptic processing and sterility assurance
Vermin was observed in an area immediately adjacent to your sterile production area.
4Aseptic processing and sterility assurance
Sporicidal agents were not used in your facility's cleanrooms and/ or ISO S classified aseptic processing area.
5Aseptic processing and sterility assurance
The ISO classified aseptic processing areas are difficult to clean and contained visibly dirty equipment or surfaces.
6Aseptic processing and sterility assurance
Disinfecting agents, cleaning pads and cleaning wipes used in the ISO 5 classified aseptic processing areas were not sterile.
7Other quality system
Use of cleaning and disinfecting agent past their expiry date.
About this record
Extracted automatically from the document US FDA published on 2020-05-04. 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.
