In November 2019 FDA issued an unusual warning letter to Greenbrier International Inc (doing business as Dollar Tree). This was based on the outcome of an inspection of their corporate headquarters in Chesapeake, Virginia ending January 18, 2019. It references the inspections of several of their CMO drug product suppliers. The form-483 identifies four multi-part observations. The second observation of the form-483 identified the lack of quality agreements with their CMOs that manufacture drug products and their contract testing laboratories and a lack of oversight of their contract partners. The law firm that responded to the form-483 for Greenbrier took the position that “Greenbrier disagrees with the Agency applying the drug manufacturing cGMPs to it…”

In contrast, the warning letter cites failure to comply with the FD&C Act and does not identify failure to comply with the regulations in 21 CFR 211. This warning letter cites inspections of foreign facilities that manufactured the “Dollar Tree’s Assured Brand drugs,” and were the subject of FDA enforcement action such as warning letters or import alerts. The warning letter focuses on the firm’s use of adulterated products from their suppliers and the use of a problematic testing laboratory recommended by the firm. The firm continued to import OTC drugs from firms that were the subject of FDA warning letters and import alerts even after the FDA communicated the warning letters to the Greenbrier COO in three of the four examples provided. FDA notes that they identified rodent feces at the manufacturing facility of one of the suppliers. Greenbrier was to respond to the warning letter and then contact the FDA to set up a meeting for further discussion. This was clearly not the end of their problems with the FDA.”

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Read the rest of this Expert Commentary by GMP Consultant Barbara W. Unger here.

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