1Aseptic processing and sterility assurance
Materials or supplies were not disinfected prior to entering the aseptic processing areas.
Inspection Record
ImprimisRx NJ — FDA 483 Findings
Inspectors Sena G Dissmeyer · Tekalign Wondimu · Amy N ChenThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Your facility design allowed the influx of poor quality air into a higher classified area.
3Other quality system
Your firm released drug product in which the strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
4Contamination control
Non-microbial contamination was observed in your production area.
5Validation and qualification
ISO 5 classified areas were not certified under dynamic conditions.
6Contamination control
Personnel did not disinfect and change gloves frequently enough to prevent contamination.
7Aseptic processing and sterility assurance
The ISO 5 classified aseptic processing areas had visibly dirty equipment or surface.
8Aseptic processing and sterility assurance
The use of sporicidal agents in the cleanrooms and ISO 5 classified aseptic processing area was inadequate.
9Aseptic processing and sterility assurance
The segregated production areas surrounding the ISO 5 classified aseptic processing area contained dust-collecting overhangs without adequate and frequent cleaning.
About this record
Extracted automatically from the document US FDA published on 2022-11-07. 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.
