Findings citing 21 CFR 210.1

Regarding your failure to establish an adequate system for monitoring environmental conditions in aseptic processing areas: We acknowledge your response regarding the failure to adequately perform active and passive air sampling within the ISO 5 area during aseptic operations, including your plan to initiate active air monitoring during filling operations. We recognize the importance of conducting effective environmental monitoring while minimizing the risk of contamination…

Regarding the textured panels in your cleanroom suite, the manufacturer’s Technical Data sheet indicates the panels with textured or smooth surface have fire, mold and mildew resistance. However, there is no statement in the Technical Data sheet supporting the panel’s suitability for cleanroom applications, especially for pharmaceutical manufacturing facilities producing products intended to be sterile. Your response is inadequate because you have not evaluated the risk…

Regarding your firm’s failure to establish the reliability of your component supplier’s test analyses (i.e., Certificates of Analysis) at appropriate intervals, as well as your failure to conduct at least one test to verify the identity of each shipment of every lot of components: We acknowledge the actions your firm has taken in response to the failure to conduct at least one identity test on each shipment of every lot of components, including APIs. Specifically, we note…

Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up. More specifically, you failed to expand your investigations into other products using the same lots of affected material (i.e. bulk bags, syringes, or (b)(4) ). Although you state that a review was conducted, the deviation report does not include a list of the specific lots that were assessed. Relying solely on trending data is not sufficient to justify the…

Regarding your firm’s failure to establish an adequate system for monitoring environmental conditions in aseptic processing areas: a. We acknowledge your firm’s actions, taken in response to your failure to implement written procedures which adequately describe the process for investigating environmental monitoring excursions. We recognize enhancements made to SOP-048 ( Environmental Monitoring Program ), including section 6.10.1 which describes the processes for conducting…

We acknowledge you have consulted with a third-party firm to provide temperature mapping and qualification of equipment at your facility to include your (b)(4) . You stated these activities and validation of the (b)(4) will be completed by May 16, 2025. We have not received any documentation showing these activities were completed. Equipment used for compounding in your ISO (b)(4) areas including goggles may impact product quality if they are not properly sterilized. In…