Friday, February 10, 2012

2011 FDA Warning Letter Review

Potentially more GMP trouble ahead for the dietary supplement industry.

2011 FDA Warning Letter Review: The Rise of GMPs:

"GMP violations dominated dietary supplement warning letters issued by the Food and Drug Administration in 2011, from failure to establish product specifications to poor record keeping, reveal FDA legal specialists Ivan Wasserman and La Toya Sutton.

2011 saw a sharp rise in cGMP-related FDA warning letters
In 2010, we saw the first warning letters for dietary supplement current Good Manufacturing Practices (GMP) violations. In 2011, the number of GMP related letters soared, representing half of the total warning letters issued by the agency.

In our annual review, we identified a total of 68 warning letters concerning dietary supplement products in 2011:"

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