1Contamination control
You produced hazardous drugs without providing adequate cleaning of work surfaces to prevent cross-contamination.
Inspection Record
Northern VA Compounders PLLC — FDA 483 Findings
Inspectors Jonathan G Matrisciano · Daniel J MinThe 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
Personnel conducted aseptic manipulations and placed equipment/supplies in an area that blocked the movement of first pass air around an open unit, either before or after it was filled with sterile product.
3Aseptic processing and sterility assurance
The <Redacted B4> intended to render fmal product sterile was not pharmaceutical grade.
4Material and supplier control
You used a non-pharmaceutical grade component in the formulation of a drug product.
5Contamination control
You produced beta-lactam drugs without providing adequate containment, segregation, cleaning of work surfaces, cleaning of utensils and cleaning of personnel to prevent cross-contamination.
6Aseptic processing and sterility assurance
The ISO 5 classified aseptic processing areas had difficult to clean, particle-generating and visibly dirty equipment or surface.
7Aseptic processing and sterility assurance
You had inadequate HEPA filter coverage and airflow over the area to which sterile product was exposed.
8Training and personnel
Personnel donned gowning apparel improperly, in a way that may have caused the gowning apparel to become contaminated.
About this record
Extracted automatically from the document US FDA published on 2023-02-21. 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.
