Storage Area – CTUs


In the QRM Weekly Bulletin, dated 4-11-14, it was identified that the C.R. Bard company had received a FDA 483, based in part, on a lack of temperature mapping studies to identify cold, hot and dead spots within drug storage areas.  Performance Validation maintains validated equipment that can measure both Temperature and Humidity, and has extensive experience in mapping various CTU type rooms and/or equipment.  See  LINK for additional information on Performance Validation’s capabilities and how PV may be able to help prevent this type of an inspection finding.