1Aseptic processing and sterility assurance
You had inadequate HEP A filter coverage and airflow over the area to which sterile product was exposed.
Inspection Record
Compounded Solutions in Pharmacy — FDA 483 Findings
Inspectors John P MisttlerThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
You used a non-pharmaceutical grade component in the formulation of a drug product.
3Aseptic processing and sterility assurance
The use of sporicidal agents in the ISO 5 classified aseptic processing area was inadequate.
4Contamination control
Non-microbial contamination was observed in your production area.
5Contamination control
You produced beta-lactam drugs without providing adequate cleaning of work surfaces and cleaning of personnel to prevent cross-contamination.
6Environmental monitoring
Unsealed, loose ceiling tiles were observed in your cleanroom.
7Aseptic processing and sterility assurance
Disinfecting agents and used in the ISO 5 classified aseptic processing areas were not sterile.
8Aseptic processing and sterility assurance
The ISO 5 classified aseptic processing areas had difficult to clean, particle-generating and visibly dirty equipment or surface.
9Aseptic processing and sterility assurance
The ISO 5 classified aseptic processing area was located within a non-classified room (segregated production area).
About this record
Extracted automatically from the document US FDA published on 2025-02-27. 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.
