In a warning letter issued to Naturecom Inc. of Lake Forest, CA, FDA included a paragraph in the latter portion of the letter that read like this:
“Additionally, we have the following comment. We acknowledge that you have voluntarily recalled your products containing 1,3-dimethylamylamine, also known as DMAA or geranium extract. Please provide this office with the status of your activities of this on-going recall and any action plan you have to prevent this from reoccurring.”
Unusual facet of warning letter
Attorney Ivan Wasserman, a partner in the firm Amin Talati Upadhye, said this is a highly unusual occurrence, to include an inquiry of this sort in a warning letter that is otherwise focused on more or less standard observances of GMP shortcomings.
“It seems odd to include it in a warning letter,” Wasserman told NutraIngredients-USA. “I have never seen a ‘comment’ like this is a communication of this sort.”
Wasserman did note that the warning letter was issued by the Los Angeles district office. District offices have the task of overseeing recalls in their areas. In late November 2016, Naturecom issued a voluntary recall for seven lots of what it called its “DMAA net weight 500g” product because “there may be presence of DMAA,” though later in teh recall notice the company said the pouch products “contain 500g of DMAA.”
The body of the warning letter pointed to what FDA said were various GMP failures on the part of thewhich firm, which mostly revolved around problems with batch records and master manufacturing records and also errors in labeling. At several points in the letter, FDA cited teh company for being too vague in its response. The following comment was typical of FDA’s opinion of the company’s response:
“We have reviewed your December 18, 2016, response; however, we are unable to evaluate the adequacy of your corrective action. Your response states that you have established MMRs for each batch size of a dietary supplement that you manufacture. However, the MMRs provided in your response failed to include actual or representative labels associated with them.”
The lesson to be learned, Wasserman said, is to be as specific as possible about what you plan to do and when you plan to do it.
“The best way to avoid a warning letter is to fix as many things as possible during the course of the actual inspection,” Wasserman said. “If there are 483s (observations of problems cited in the inspection report), you need to be very specific in your responses, not only about what you intend to do but the time frame within which you intend to do it. FDA does not like generalities.”