1Training and personnel
Personnel manually contacted the inner surface of the container or closure.
Inspection Record
Medoz Pharmacy of Polk Inc — FDA 483 Findings
Inspectors Jessica L PressleyThe 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
Environmental monitoring was not performed in your aseptic processing areas.
3Validation and qualification
IS0-5 classified areas were not certified under dynamic conditions.
4Other quality system
Venn in was observed in an area immediately adjacent to your production area.
5Contamination control
You produced hazardous drugs without providing adequate cleaning of work surfaces and cleaning of personnel to prevent cross-contamination.
6Contamination control
Personnel did not disinfect and change gloves frequently enough to prevent contamination.
7Aseptic processing and sterility assurance
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities and conditions that provide a challenge to aseptic operations.
8Other 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.
9Equipment and facility
Vermin was observed in your production area.
10Training and personnel
Personnel donned gowning apparel improperly, in a way that may have caused the gowning apparel to become contaminated.
11Aseptic processing and sterility assurance
Your firm exposed stock solutions, intended to be sterile, to lower than ISO 5 quality air.
12Aseptic processing and sterility assurance
Sporicidal agents were not used in your facility's cleanrooms and/or ISO 5 classified aseptic processing area.
13Aseptic processing and sterility assurance
The ISO 5 classified aseptic processing areas had visibly dirty equipment or surface.
14Equipment and facility
HEPA filters were not sealed around each perimeter to the support frame.
About this record
Extracted automatically from the document US FDA published on 2019-11-12. 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.
