ABSTRACT
Finished products may be returned to the manufacturer for a variety of reasons, including perceived quality defects, and also possibly because of slow retail sales, overstocks, ordering the wrong quantity, a retailer going out of business, or any of a number of other reasons. Also, in the event of a recall, goods are returned to the manufacturer as discussed in chapter 23. Therefore, §111.503 mandates the establishment and following of a written procedure (SOP) for fulfilling the requirements of Subpart N of the GMPs titled Returned Dietary Supplements.
