Application number that medical device manufacturers must file, to notify FDA of their intent to market a medical device at least 90 days in advance. Also known as Premarket Notification – PMN. This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, … Read more


Japanese method for workplace organization. The five S’s are seiri, seiton, seiso, seiketsu, and shitsuke or sorting, straightening, shining, standardizing, and sustaining. The picture shows a 5s organized tool system. Every tool has it’s place and if it is not there it is obvious.      


Active Pharmaceutical Ingredient


Annual Product Review


Acceptance Quality Level (Limit)


Corrective Action Preventative Action – This is a process for correcting and preventing errors during a procedure. A corrective action may be implemented as the result of a non conformance or deviation. The corrective action may be a document change, training, or any documented activity that is designed to stop the re-occurrence of the deviation. … Read more


Center for Biologics Evaluation and Research


Center for Drug Evaluation and Research


Center for Devices and Radiological Health


Code of Federal Regulations governs manufacturing requirements per the FDA.