1Stability and storage
There is no written testing program designed to assess the stability characteristics ofdrug products.
Inspection Record
Blue Ridge Pharmacy and Compounding Center — FDA 483 Findings
Inspectors Viviana MattaThe 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
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
3Aseptic processing and sterility assurance
Procedures designed lo prevent microbiological contamination ofdrug producls purporting to be sterile are not established and followed.
4Aseptic processing and sterility assurance
Each batch ofdrug product purporting to be sterile and pyrogen-free is not laboratory tested to detennine conformance to such requirements.
5Process validation
Written production and process control procedures are not documented at the time ofperfonnance.
6Training and personnel
Clothing of personnel engaged in the processing ofdrug products is not appropriate for the duties they perform.
7Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
8Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include adequate validation ofthe sterili7.ation process.
9Deviation, CAPA, and investigation
Written records are not made of investigations into the failure ofa batch or any of its components to meet specifications.
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.
