1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
Inspection Record
Compound Preferred LLC — FDA 483 Findings
Inspectors Kenneth O Gee · Sangeeta M KhuranaThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
You did not make adequate product evaluation and take remedial action where actionable microbial contamination was found to be present in the ISO 5 classified aseptic processing area during aseptic production.
3Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure that drug product containers conform to appropriate standards of identity, strength, quality and purity.
4Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
5Equipment and facility
Routine calibration of automatic and mechanical equipment is not performed according to a written program designed to assure proper performance.
6Equipment and facility
The flow of components, drug product containers, closures and in-process materials through the building is not designed to prevent contamination.
7Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
About this record
Extracted automatically from the document US FDA published on 2022-10-19. 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.
