The FDA has banned the OTC products of a small Canadian drugmaker after discovering it was using ingredients from a supplier already on its import alert list.
The FDA added Aztex Enterprises to its import alert list the day before it issued a warning letter to the Burlington, Ontario-based company. In that letter, the FDA suggested that if the company wants to do business in the U.S., it should get a consultant to help it learn the standards.
The FDA said that before the FDA showed up in June, Aztex had not set up a quality unit or even written procedures for one. It also had no written procedures for labeling or handling complaints.
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One area the FDA focused on was Aztex’s lack of steps for qualifying suppliers. The products of one of Aztex suppliers are considered adulterated and not allowed into the U.S. The FDA did not name the supplier or the ingredient but told Aztex that its use of adulterated ingredients was responsible for its products being excluded from the market.
Other drugmakers have been dealt the same penalty by the FDA, in some cases for using potentially dangerous ingredients.
In 2014, the FDA took similar actions against China's Beijing Shunxin Meihua Bio-technical after it appeared the Chinese company was getting some of its raw materials from a supplier that was on an FDA watch list of suspect companies that don't carefully monitor the source of their materials. They were unable to do a thorough investigation because the Chinese company "repeatedly" refused to let inspectors into the production area or to review records. In response, the FDA put Shunxin Meihua Bio-technical on its import alert list and issued a warning letter.