Dietary Supplement Inspection
Late 2017 a dietary supplement private labeler was inspected by FDA. This was their second inspection in two years. At the first inspection there were various observations noted by the FDA inspector. During this second inspection there were zero observations issued. The dietary supplement private labeler and our firm had been working diligently to establish a compliance program that would address all the requirements under FDA good manufacturing practices.
According to the FDA if you are responsible for the label, then your company is also responsible to ensure that the manufacturer is producing what you requested and that your contract manufacturer is complying with good manufacturing practices. This particular supplement private labeler thought that the manufacturer was responsible for all "good manufacturing practices".
After consistently implementing new written policies and procedures and training the employees on what their requirements are under the regulations this client was able to breathe easy before, during and after the inspection.
Practice area(s): Other