Wednesday, November 27, 2019

Warning Letter of the Week: Dollar Tree edition

From an epistle from the Center for Drug Evaluation and Research to the President and CEO of Greenbrier International, Inc dba Dollar Tree (emphases mine):
The U.S. Food and Drug Administration (FDA) inspected your corporate headquarters, Greenbrier International, Inc. (Greenbrier) (FEI 3005269673) at 500 Volvo Parkway, Chesapeake, Virginia, from January 14 to 18, 2019 after FDA inspections revealed violative conditions at multiple foreign drug manufacturers that supplied drugs to your distribution network. Firms inspected by FDA included contract manufacturers used to manufacture Dollar Tree's Assured Brand drugs…. 
...Our inspection and review of import data revealed the following: 
2. lmport records reviewed indicated that your firm received various [redacted] and [redacted] drug products from Hangzhou Zhongbo Industrial Company, Ltd., FEI 3008229416, from October through December of 2018. An inspection of Hangzhou Zhongbo Industrial Company, Ltd. in April of 2018 revealed significant CGMP violations, including the failure to test each batch of drug for conformance with specifications prior to release (21 CFR 211.165(a)). As a result of this and other violations, Hangzhou Zhongbo lndustiial Company, Ltd. was placed on Import Alert 66-40 on September 28, 2018 and was issued a warning letter on November 27, 2018. FDA copied your COO on the outgoing warning letter.... 
...We also note that Greenbrier has, at various points in time, used contract manufacturers and suppliers with histories of significant drug CGMP violations. For example, our inspections revealed that beyond the facilities detailed above, your firm has used the following contract manufacturers and suppliers: 
2. Bicooya Cosmetics Limited, FEI 3010671652, which was issued a warning letter on August 11, 2017. This firm was also placed on Import Alert 66-40 on June 29, 2017, for, among other things, not testing finished drug products prior to distribution and for rodent feces found throughout the manufacturing facility. FDA copied your COO on the warning letter.
What’s a little rodent feces between friends? 

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