October 31, 2012
WASHINGTON In a warning letter sent last month to Global Source Management & Consulting, FDA cited numerous violations of federal law and regulations after inspecting the company's facilities in Sunrise, Fla.
The government agency contends the company is unlawfully marketing its products as being able to treat diseases such as Arthritis and Alzheimer's. The products also fail to meet Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, FDA wrote in the letter to the president of Global Source Management & Consulting: Gary R. Durbin. An inspection revealed such regulatory violations as failure to establish certain specifications and written procedures among other omissions.
"Further, even if your products listed below, were not unapproved new and misbranded drugs, they would be misbranded dietary supplements" under federal law, FDA said, pointing out what it considers omissions and misrepresentations on labels of various products.
Global Source Management & Consulting also faced accusations that its actual facility has problems, including inadequate protection against pests and insufficient ceilings. For instance, the agency said it observed "a live lizard approximately two feet from the packaging and labeling table". And during an inspection, an "investigator observed damage from water on a ceiling tile over your raw ingredients storage area and in the restroom," FDA said.
Emma R. Singleton, Director of the Florida District Office with FDA, sent the letter on Sept. 10, and as is the protocol, Global Source Management & Consulting was given 15 days to respond.
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