The FDA’s inspection from October 2012 found “visible powder” on the equipment, floors, and walls of the facility that “could lead to a cross-contamination” of the two types of APIs manufactured at the Gunma-based facility. Hundreds of insects were also observed by FDA inspectors in the insect catchers located in the processing areas of the facility.
Meanwhile, Asada also failed to establish procedures “to review process validation, change management documentation, release of raw materials, and to approve or reject batch records. Moreover, your firm failed to ensure the use of an effective system for calibrating critical manufacturing equipment and to provide employees with CGMP training,” the FDA said.
In terms of the raw materials Asada uses to make its APIs, the FDA found the company failed to perform identity testing on them and failed to verify the reliability of certificates of analysis for these raw materials at appropriate intervals.
Representatives from Asada also told FDA inspectors that the company has no stability program for any of the APIs produced at the facility or any data to support the expiration date provided on the label for its products.
The quality unit’s failure “to review, release, or reject finished API products,” and its failure “to perform annual product quality reviews” were also called out in the letter.
In addition to the warning letter, the FDA has recently put the company on import alert, which means their products are not allowed to be shipped to the US. Asada did not respond to a request for comment by press time.