1Aseptic processing and sterility assurance
Test procedures relative to appropriate laboratory testing for sterility are not followed.
Inspection Record
RC Outsourcing LLC — FDA 483 Findings
Inspectors Matthew B Casale · Jazmine N StillThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Training and personnel
Clothing of personnel engaged in the manufacturing, processing and packing of drug products is not a ppropriate for the duties they perform.
3Other quality system
DE PARTMENT OF HEALTH AND HUMAN SERVI CES D ISTRICT ADDRESS AND PHONE NUMBER OATE(S) OF INSPECTION 6751 Steger Drive 3/27/201 7 - 3/31/201 7 - 3097 3011967886 (513)679- 2700 Fax : (513)679- 2772 SUED Raymond R.
4Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any o f its components to meet any of its specifications whether or not the batch has been already distributed.
5Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strengt h, quality and purity.
6Laboratory and QC controls
The accuracy and reproducibility of test methods have not been established and documented.
7Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and written.
8Laboratory and QC controls
Each batch of drug product purporting to be pyogen-free is not laboratory tested to determine conformance to such requirements.
9Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental 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.
