1Aseptic processing and sterility assurance
Personnel engaged in aseptic processing were observed wearing non-sterile gloves.
Inspection Record
Thrive Health and Wellness 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
Use of a disinfectant in a manner insufficient to achieve adequate levels of disinfection.
3Equipment and facility
Production areas have difficult to clean or contain porous, particle generating, or visibly dirty equipment or surfaces.
4Aseptic processing and sterility assurance
Personnel engaged in aseptic processing were observed with exposed hair and skin.
5Aseptic processing and sterility assurance
Failures to conduct media fills that simulate aseptic production operations.
6Aseptic processing and sterility assurance
Lack of a certified 1SO-5 classified area for sterile compounding Specifically, Your firm fills syringes intended for subcutaneous injection by withdrawing sterile solution from vials on a benchtop table, located in an unclassified room for the following products: • Semaglutide for .injection • Tirzepatide for injection • Cyanocobalamin for injection • Lipoboost CB-complex) for injection • Sermorelin for injection The dosage of each product varies among patients or across different treatment levels., Your firm produced an average of approximately <Redacted B4> syringes a week.
About this record
Extracted automatically from the document US FDA published on 2025-05-07. 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.
