FDA issues warning letter to Dollar Tree stores for receiving potentially unsafe drugs
The FDA issued a warning letter to Greenbrier International, Inc., doing business as Dollar Tree, for receiving over-the-counter (OTC) drugs produced by foreign manufacturers found to have serious violations of federal law. The warning letter outlines multiple cGMP regulation violations at contract manufacturers used to produce Dollar Tree’s Assured Brand OTC drugs as well as other drug products like acne treatment pads that are sold at Dollar Tree and Family Dollar stores.
The warning letter details Dollar Tree’s receipt of adulterated drugs from manufacturers that received FDA warning letters in 2018. The warning letter also details Dollar Tree’s use of contract manufacturers that also received warning letters for similar issues between 2016 and 2019. Manufacturers that received these warning letters were placed on import alert, which are used to prevent potentially violative products from being imported into the U.S. market. The FDA notified Dollar Tree of warning letters sent to these manufacturers at the time the warning letters were sent.
The warning letters sent to the contract manufacturers used by Dollar Tree show a pattern of serious violations of the law, such as not testing raw materials or finished drugs for pathogens and quality. Specifically, the inspections revealed that the firm received Acne Treatment Pads from Shanghai Weierya Daily Chemicals which was found to be in violation of several cGMP regulations, “including the failure to conduct component identity testing and the failure to test each batch of drug for objectionable microorganisms prior to distribution”. The inspections also indicated that drug products that the firm received from Hangzhou Zhongbo Industrial Company, Ltd., also was in violation of cGMP regulations, “including the failure to test each batch of drug for conformance with specifications prior to release”.
The FDA’s warning letter to Dollar Tree details the corrective actions the agency requested. Among those, the FDA has requested the company implement a system to ensure that they do not import adulterated drugs due to Greenbrier’s history with using contract manufacturers who have been found to be in violation of various cGMP regulations in the past.
From mdi Consultants experience working with private label “importers/distributors”, we also often see these companies attach a false sense of security to the fact they are not physical product manufacturers. FDA has clearly indicated on numerous occasions it is the company whose name is on the product label that has the ultimate responsibility for product’s safety and effectiveness. Accordingly, private labels imports/distributors must not blindly rely on their foreign or domestic contract manufacturers and instead maintain a strong program of regulatory compliance over their suppliers. Not doing so will lead to private label importers/distributors getting into FDA regulatory problems themselves as evidenced by the latest warning letter issued to Greenbrier International, Inc.
It is critical that private label initial importers/distributors maintain a strong oversight of their suppliers. This includes initial supplier selection, periodic performance assessments and supplier ratings. In addition, the product owners must make a requirement of their contract agreement they are to be informed by the manufacturers of the upcoming FDA inspections and the outcome of these inspections as well as any FDA follow up, e.g., issuance of a warning letter. You cannot assume that if you do not hear anything from your suppliers, EVERYTHING is ok. When deciding to outsource your product manufacturing, you need to be very proactive, each and every day, with your contract manufacturers. Otherwise, you are running a risk of FDA coming down on your operations and disrupting your business by blocking the entry of contract manufactured products from foreign suppliers.
mdi Consultants has been involved with many clients on various projects and specializes in dealing with FDA inspections, compliance, foreign suppliers, and the warning letters. If you need any assistance with FDA inspections or other regulations, please contact us for a free consultation.
We will continue to monitor any updates pertaining to the warning letter moving forward. If you have any questions about FDA inspections, warning letters, how this can affect your company and how we can help or for any of your regulatory requirements, feel free to contact us at firstname.lastname@example.org or use our contact form.