Are you a small to medium sized dietary supplement marketer? Do you have a warehouse where you store and ship dietary supplements or functional foods to your customers?. Do You have contract manufacturers that provide you with product? Do you have cGMP Standard operating procedures written and in place for your operation. Are they kept up to date? Did you know that the FDA inspectors can show up unannounced and request an inspection of your facility?
Dietary supplement distributors, marketers and brands are classified as Holding Facilities for dietary supplements. As such they are required to comply with cGMP’s under Subpart M of the CFR 21 part 111 or 110 cGMP rules ( for landfoods) for Holding and Distributing Facilities. This means having written S.O.P’s (Standard Operating Procedures and an accompanying Document Management Control System (DMCS) in place.
First and foremost is the risk of an audit by an outside U.S. regulatory agency (ie. FDA, USDA).
This would create a chain of events. The holding or distributing company would be issued a FDA 483.
A Form 483, also called “Inspectional Observations,” is a list of conditions or practices that indicate a potential violation of the FDA’s requirements. The observations are listed in descending order of importance. This is not an all-inclusive list, but more of a snapshot of possible issues noted at the site.. FDA law is unique in that the Agency does not have to prove a product is injurious to public health, but only that there are conditions in which this may occur (e.g. not following the law and its implemented regulations).
The FDA Form 483 notifies the company’s management of objectionable conditions. At the conclusion of an inspection, the FDA Form 483 is presented and discussed with the company’s senior management. Companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and then implement that corrective action plan expeditiously. (Usually within 15-30 days)
The cost of having a document management and control system is very manageable. The advantages and benefits are increased efficiency, safety, and reduced risk in a product recall event.
Nutrition50 has expertise in the creation of both SOP’s and a DMCS for your Product Holding or Distribution Facility. It’s basic, affordable, and can be accomplished in a short period of time.