1Aseptic processing and sterility assurance
The|) sterilization validation ofdirect and indirect sterile product-contact items is not sufficient to demonstrate sterility assurance: a.
Inspection Record
PharmaEssentia Corp. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
The air flow pattern testing studies did not include all operations such as setup and assembly, normal and unusual interventions, unassisted equipment operation including filling to demonstrate unidirectional airflow within the Class A classified Restricted Assess Barrier System (RABS).
3Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofPM arug product purporting to be sterile are not established and followed.
4Other quality system
The visual inspection procedures are inadequate to addresseecetective filled drug product trends.
5Material and supplier control
The incoming material are released for manufacturing operations prior to completing the final testing and, thus, there is no assurance that incoming material meets the specification and suitable for manufacturing.
6Deviation, CAPA, and investigation
The deviations and/or investigations are not always raised due to nonconformance events or incidents are not adequately investigated.
7Computer system validation
Adequate procedural controls to protect the electronic data acquisition systems have not been established.
8Other quality system
The I arug product manufacturing process is not adequately controlled or monitored to ensure that process limits conform to specifications.
9Other quality system
Procedures to control environmental conditions have not been adequately established.
About this record
Extracted automatically from the document US FDA published on 2026-07-10. 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.
