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Specific findings from FDA inspections include failure to monitor cleanroom environments where sterile drugs are prepared, inadequate sterilization of equipment used in drug production, release of a batch of vitamin B6 despite microbial contamination detected in the production room, incomplete cleaning validation for equipment used in compounding implantable pellets, and repeat violations that were identified in previous inspections but not corrected

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Additionally, for ACOs with significant EHR vendor concerns, when issues of potential noncompliance with certification requirements are unresolvable, we note that the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC) has provided a complaint process for ( certified products available to the public at