FDA 483 - RC Compounding Services, LLC - February 07, 2013

This FDA Form 483 document outlines observations made during an inspection of a facility involved in the repacking of Avastin. The inspection revealed three key deficiencies related to quality control and manufacturing processes.

Firstly, the facility's testing and release procedures for drug products are inadequate. Specifically, each lot of repacked Avastin is released for distribution without appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient. Assay and identity testing are not performed for these lots.

Secondly, the facility fails to perform appropriate laboratory testing for each batch of drug product required to be free of objectionable microorganisms. Sterility testing is not conducted for each lot of repacked Avastin, raising concerns about potential microbial contamination.

Finally, the facility lacks established control procedures to validate the performance of manufacturing processes that may cause variability in in-process material and the final drug product. A process validation study has not been performed for the Avastin repacking process, indicating a lack of robust process control and potential for inconsistent product quality. These observations highlight significant gaps in quality control and manufacturing validation for the repacked Avastin product.