In a letter to the Chief Executive Officer of Bioiberica, SAU, the Center for Drug Evaluation and Research notes these issues:
1. Failure to establish written procedures to monitor the progress and control the performance of processing steps that may cause variability in the quality characteristics of your intermediates and API.
You failed to establish appropriate monitoring and controls for reworking batches of [redacted] USP, API. In 2020 and 2021, approximately 23 batches of [redacted] USP, API were reworked in your industrial [redacted] because of microbiological out-of-specification or non-conforming high [redacted], a class 3 residual solvent, content results. The use of the industrial [redacted] was not part of the established process validation for [redacted] USP, API. The investigator documented this [redacted] was used to rework multiple batches from [redacted] to as many as [redacted] times until acceptable results were obtained. No studies had been performed to establish the effectiveness of this rework step. Additionally, your industrial [redacted] was not equipped with real time [redacted] monitoring or a [redacted] summary to monitor the performance of the [redacted].
No product too holy to be reworked, folks! (Guessing that they chose to use a different piece of equipment than what they laid out earlier.)