1Aseptic processing and sterility assurance
Disinfecting agents and cleaning pads and cleaning wipes used in the ISO 5 classified aseptic processing areas were not sterile.
Inspection Record
New England Life Care, Inc. — FDA 483 Findings
Inspectors Robert J MartinThe 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
You had inadequate HEPA filter coverage and airflow over the area to which sterile product was exposed.
3Aseptic processing and sterility assurance
Personnel moved rapidly in the vicinity of open sterile units and instruments, which disrupted the airflow and increased the risk of bringing lesser quality air into the ISO 5 classified aseptic processing area.
4Contamination control
Non-microbial contamination was observed in your production area.
5Contamination control
You produced beta-lactam drugs without providing adequate cleaning of utensils to prevent cross-contamination.
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.
