Problems can and do occur at any point in the manufacturing process and the manufacturing of sterile injectables is particularly complex and involves many steps where things can go wrong. When problems occur at any step in the process, FDA encourages firms to notify FDA of any potential supply issues so we can help address the problem. Manufacturers are required to report discontinuances to FDA regardless of whether they intend to discontinue the product permanently or are facing only a temporary interruption of supply.
