FDA Warns Company Over Drug Listing Failures

June 14, 2017

The agency sent a warning letter to A-S Medication Solutions LLC after it found the company didn’t comply with drug listing file requirements.

FDA sent a warning letter to A-S Medication Solutions LLC, dated June 5, 2017, that stated the company had failed to comply with drug listing requirements and, therefore, the agency is removing the company’s drug listing files from public viewing until they are corrected. The warning letter follows a review by the agency of the company’s listing files between May 2016 and March 2017.

In the letter, the agency cites section 510 of the Federal Food, Drug, and Cosmetic Act that requires companies to register with FDA and list all the drugs they manufacture for commercial distribution. That information must be updated twice yearly and include any drugs not previously listed, discontinued, or any material changes to previously listed information.

The agency stated it randomly reviewed drug listing files of A-S Medication Solutions LLC and found submissions that did not comply with the requirements. FDA notified the company of the deficiencies and was assured by the company that the listings would be corrected. FDA stated in the letter, however, that the company had failed to correct the listings. “A recent analysis of A-S Medications’ current drug listing files has revealed that the old violations have not been entirely addressed and a number of new drug listings submitted by your firm after our May 19th meeting also do not meet the listing requirements,” the agency stated in the letter.

Because of this failure to comply, the agency decided to remove the company’s drug listing files from public viewing on June 5, 2017 to protect the public from inaccurate information. FDA stated in the letter that the listings will be removed until the company can demonstrate, and the agency can confirm, that the firm has “implemented a process that will ensure that your listing files are being submitted correctly and in accordance with all the drug listing regulations and requirements.”

Source: FDA