1Deviation, CAPA, and investigation
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
Inspection Record
Tri-Med, Inc. dba Advanced Care Infusion-Shelby — FDA 483 Findings
Inspectors Jeffrey D. MengThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
There is no written testing program designed to assess the stability characteristics ofdrug products.
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.
5Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written and followed.
6Training and personnel
Clothing ofpersonnel engaged in the processing of drug products is not appropriate for the duties they perform.
7Laboratory and QC controls
Testing and release ofdrug product for distribution do not include appropriate laboratory determination ofsatisfactory conformance to the identity and strength ofeach active ingredient prior to release.
8Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
9Aseptic processing and sterility assurance
Each batch ofdrug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.
10Aseptic processing and sterility assurance
Aseptic processing areas are deficient in that floors, walls, and ceilings are not smooth and/or hard surfaces that are easily cleanable.
11Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
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.
