1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
Inspection Record
Excel Vision — FDA 483 Findings
Inspectors Eileen A. Liu · Angelica M. HernandezThe 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
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
3Laboratory and QC controls
Laboratory records do not include the initials or signature ofa second person showing that the original records have been reviewed for accuracy, completeness, compliance with established standards.
About this record
Extracted automatically from the document US FDA published on 2026-04-28. 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.
