1Material and supplier control
Materials were exposed to lower than ISO 5 quality air.
Inspection Record
Advanced Nutriceuticals, LLC — FDA 483 Findings
Inspectors Taichun QinThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The ISO 5 classified area is located within a non-classified room.
3Other quality system
Use of non-sterile cleaning pads and cleaning wipes in the ISO 5 area.
4Aseptic processing and sterility assurance
Failure to conduct media fills that closely simulate aseptic production operations under the worst-case, most-challenging, and stressful conditions.
5Training and personnel
Personnel were observed moving quickly in a critical area or in an area immediately adjacent to a critical area likely causing disruption of unidirectional airflow.
6Equipment and facility
Production areas have difficult to clean or contain porous, particle generating, or visibly duty equipment or surfaces.
7Equipment and facility
Vermin or other animals or evidence of their presence was observed in the areas adjacent to production areas.
8Other quality system
Lack of disinfection of supplies at each transition from areas of lower quality air to areas of higher quality air.
9Equipment and facility
Use of a sporicidal agent in the facility's was infrequent.
10Contamination control
Contamination was observed in your production area and areas adjacent to production areas.
About this record
Extracted automatically from the document US FDA published on 2025-06-20. 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.
