1Other quality system
The ISO 5 classified area is located within a non-classified room.
Inspection Record
Rx Compounding Inc. dba Nora Apothecary — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Validation and qualification
The certification of ISO 5 classified area is not representative of its condition of use.
3Environmental monitoring
Chemical sanitizing agents are not used in your facilities cleanrooms.
4Aseptic processing and sterility assurance
Equipment, materials, and/or supplies are not adequately disinfected prior to entering the aseptic processing areas.
5Aseptic processing and sterility assurance
Personnel engaged in aseptic processing were observed wearing non-sterile gloves.
6Aseptic processing and sterility assurance
Personnel were observed perform ing aseptic manipulations that blocked the movement of first pass air around an open unit, whether before or after it is fi lled with sterile product.
7Aseptic processing and sterility assurance
The environmental monitoring is performed is not representative of aseptic conditions.
8Contamination control
Beta-lactam drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination.
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.
