1Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Inspection Record
South Coast Specialty Compounding, Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
5Training and personnel
Clothing of personnel engaged in the processing of drug products is appropriate for the duties they perform.
6Contamination control
There was a failure to handle and store drug product containers and closures at all times in a manner to prevent contamination.
7Equipment and facility
Routine calibration of equipment is not performed according to a written program designed to assure proper performance.
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.
