1Contamination control
You produced beta-lactam drugs without providing adequate containment, segregation and cleaning of work surfaces to prevent cross-contamination.
Inspection Record
New England Life Care, Inc. — FDA 483 Findings
Inspectors Edmund F MrakThe 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
Disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing areas were not sterile.
3Aseptic processing and sterility assurance
You had inadequate HEPA filter coverage and airflow over the area to which sterile product was exposed.
4Aseptic processing and sterility assurance
Personnel engaged in aseptic processing were observed with exposed hair.
5Aseptic processing and sterility assurance
Materials or supplies were not disinfected prior to entering the aseptic processing areas.
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.
