FDA Warns Canadian, Indian Drugmakers

Posted 31 October 2017 | By Zachary Brennan 

FDA Warns Canadian, Indian Drugmakers

The US Food and Drug Administration (FDA) on Tuesday released two warning letters sent to Burlington, Ontario-based Aztex Enterprises and Raigad, India-based Kim Chemicals Private Ltd.

Kim Chemicals

According to the warning letter sent 16 October, FDA said that although Kim Chemicals promised to set up a GMP system with written procedures, the company’s plan lacks details. The firm on 21 August was added to FDA's import alert list for drugs that have not met GMPs.

During its inspection, FDA said it found multiple batches of the firm’s Vaporizing Chest Rub "failed to meet finished product specifications, including active ingredient content." Company staff also informed FDA’s investigator that batches are not routinely tested and the firm "re-uses test results from a past batch produced several years ago, and enters those results on certificates of analysis for new batches."

In terms of analytical test results, FDA said the firm documents finished product analysis on a pad of paper, transcribes the test results onto a certificate of analysis and then destroys the piece of paper.

"There is no assurance that the testing was conducted in the first place, and there is no record that any associated calculations were performed," the warning letter says.


The letter sent to Aztex, dated 20 October, relates to a two day inspection from FDA in June in which the agency found the company does not have a formal quality unit or written procedures for labeling operations and complaint handling for its over-the-counter drugs shipped to the US.

FDA also said the company uses a supplier that is listed on the agency’s import alert list for firms that have not met drug GMPs.

Kim Chemicals Private Ltd. 10/16/17

Aztex Enterprises Ltd. 10/20/17

Categories: Regulatory News

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