1Equipment and facility
Your facility design allowed the influx of poor quality air into a higher classified area.
Inspection Record
MasterPharm LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Contamination control
Non-microbial contamination was observed in your production area.
3Validation and qualification
1S0-5 classified areas were not certified under dynamic conditions.
4Training and personnel
There is a lack of adequate personnel sampling.
5Contamination control
Hazardous drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination.
6Aseptic processing and sterility assurance
The ISO classified aseptic processing areas have difficult to clean, particle-generating and visibly dirty equipment and surfaces.
About this record
Extracted automatically from the document US FDA published on 2020-07-29. 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.
