14/15 September 2021
The FDA Warning Letter issued to the Canadian manufacturer Aztex Enterprises Ltd. on 20 October 2017 is based on an FDA inspection conducted in June 2017. The Warning Letter refers to the company's reply from 12 July 2017. The company's response was criticised as inadequate. It had confirmed that the observations from the FDA inspection would be remedied. However, the FDA found that the reply was not elaborate enough. Also, no adequate supplier evaluation was conducted.
It was further criticised that the company had no written instructions for packaging processes and the handling of complaints concerning OTC (over the counter) products to be delivered to the USA. Moreover, suppliers had not been sufficiently qualified.
Aztex Enterprises sourced products from a supplier who was listed on an FDA Import Alert. Since the company obtained and used adulterated materials, the products produced by them are also subject to these rules. That is why the FDA declared an immediate import ban on Aztex Enterprises.
The company may not have any new products approved until all violations have been rectified in their entirety.
For more details please see the FDA's complete Warning Letter to Aztex Enterprises.