Warning Letter Highlights Testing and Documentation Problems

Dallas, TX—A recent warning letter sent to Coats International following a good manufacturing practices inspection underscores several out-of-compliance issues that inspectors are finding at dietary supplement plants. Such observation trends were recently discussed by a staff member from the U.S. Food and Drug Administration (FDA) at an industry tradeshow (see “GMP Report Card from FDA” in the July issue of WholeFoods). Here, some of the compliance issues with respect to Coats International are presented so industry can get a sense of the types of problems FDA is noting.

Coats responded in detail to FDA’s Form 483 after the inspection, but according to the agency, the company still had not made adequate corrections. Such outstanding issues, according to FDA, include the following:

* The company was sited for neglecting to conduct “appropriate” identity testing of the aloe raw material used in its Herbalife Ready Herbal Aloe for Digestive Health and Herbalife Herbal Aloe Concentrate for Digestive Health dietary supplements.  FDA felt that the company didn’t specify exactly how it would conduct identity testing and what test it would use if identity methodology could not be replicated.

* Coats created new standard operating procedures for several aspects of its manufacturing process, but did not submit a copy to FDA for approval.

* The company implemented several new quality control procedures, but did not offer evidence to FDA that the staff was trained how to follow them.

* After receiving the Form 483, batch records were revised (as FDA requested), but the company didn’t provide a copy of the revisions to the agency.

* Coats didn’t have corrective actions in place for when specifications aren’t met, and said it would resolve the issue by adjusting its batch production records rather than its master manufacturing records.

Published in WholeFoods Magazine, July 2010 (published online ahead of print, May 27)