1Aseptic processing and sterility assurance
Biological indicators are not used properly to verify the adequacy ofthe sterilization cycle.
Inspection Record
Inventive Infusion Solutions, LP — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Disinfecting agents and used in the ISO 5 classified aseptic processing areas were note sterile.
3Aseptic processing and sterility assurance
Non-sterilized and Non-depyrogenated equipment was used in sterile drug production.
4Other quality system
Endotoxin level is not tested on the finished drug products.
5Contamination control
You produced beta-lactam drugs without providing adequate containment, segregation, cleaning of work surfaces, cleaning ofutensils and cleaning of personnel to prevent cross-contamination.
6Environmental monitoring
Unsealed, loose ceiling tiles were observed in your cleanroom.
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.
8Contamination control
Personnel did not disinfect to prevent contamination Specifically, On 8/22/2018 and 8/28/2018, operator <Redacted B4> was observed with exposed facial skin while cleaning the surfaces in side the ISO 5 area of <R edacted B4> Hood.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
