1Aseptic processing and sterility assurance
Disinfecting agents used in the ISO 5 aseptic processing areas are not sterile.
Inspection Record
Nutrishare Inc — FDA 483 Findings
Inspectors Jazmine N. StillThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
The facility design is designed and operated in a way that permits poor flow of materials.
3Environmental monitoring
Unsealed, loose ceiling tiles were observed in your cleanroom.
4Aseptic processing and sterility assurance
The use of sporicidal agents in the cleanrooms and ISO 5 aseptic areas is inadequate.
5Contamination control
You produced beta-lactam drugs without providing adequate segregation, cleaning of work surfaces and cleaning o f personnel to prevent cross-contamination.
6Aseptic processing and sterility assurance
Materials or supplies were not disinfected prior to entering the aseptic processing areas.
7Training and personnel
Personnel donned gowning apparel improperly, ina way that may have caused the gowning apparel to become contaminated.
8Validation and qualification
ISO 5 classified areas were not certified under dynamic conditions.
9Aseptic 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.
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.
