1Aseptic processing and sterility assurance
Each batch of drug product purporting to be sterile is not laboratory tested to determine conformance to such requirements.
Inspection Record
Oregon Compounding Centers, Inc., dba Creative Compounds — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
An adequate number of batches of each drug product are not tested to determine an appropriate expiration date.
3Laboratory and QC controls
Testing and release of drug product for distribution co not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.
4Training and personnel
Clothing of personnel engaged in the manufacturing processing of drug products is not appropriate for the duties they perform.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air s upply that is filtered through high-efficiency particulate air filters under positive pressure.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
7Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning disinfecting the room and equipment to produce aseptic conditions.
8Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed.
9Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation of the sterilization process.
10Deviation, CAPA, and investigation
Written records are not made of investigations into t e 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.
