1Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
Inspection Record
Total Pharmacy Services, 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 ofdrug products purporting to be sterile do oot include validation oflhe Slerilization process.
3Aseptic processing and sterility assurance
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.
4Training and personnel
Clothing of personnel engaged in the manufacturing, processing, packing and holding of drug products is not appropriate for the d uties they perform.
5Aseptic processing and sterility assurance
Aseptic processing areas are def~ient regarding the system fo r monitoring environmenta1 conditions.
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.
