Warning letter to Utah firm highlights contract manufacturing, FSMA questions

By Hank Schultz

- Last updated on GMT

© Getty Images / bankrx
© Getty Images / bankrx
A recent warning letter sent to a Utah company by the US Food and Drug Administration lists various GMP violations, including a lack of allergen warnings, something that will only accelerate as FSMA implementation goes into full swing.

In a letter to Biotek, Inc​.,  of Layton, UT, FDA said an inspection of the company’s plant showed serious GMP failures. Those failures included a lack of written procedures pertaining to how the company’s products, which are made by a contract manufacturer, will be subjected to quality operations before shipment.

Specifically, the company had no master manufacturing records or batch production records that pertained the packaging and shipment of the products that it received. Nor did it have any specifications for the products it received, or any method for ensuring that the products met specification before they were repackaged and shipped.

The warning letter also noted numerous labeling violations.  Chief among these was a failure to mention soy, in the form of soy lecithin, as a major allergen on the label.  As enforcement of the Food Safety and Modernization Act (FSMA) goes into full swing, experts say dietary supplement companies will have to pay increasing attention to this and other aspects of the new law.  This is the second time in recent months that an official FDA enforcement communication to a dietary supplement manufacturer has specifically cited an allergen call-out failure.

Supplement firms need to mind their FSMA P’s and Q’s

Larisa Pavlick, vice president of regulatory and compliance for the United Natural Products Alliance (UNPA), said the question of allergens doesn’t come into play very often in supplement manufacturing, but that doesn’t mean that dietary supplement manufacturers don’t need to be up to date on the latest requirements under FSMA.

“There’s this whole misunderstanding out there that dietary supplement manufacturers are not subject of FSMA.  They are exempt for only two of the subsections of FSMA,”​ Pavlick told NutraIngredients-USA.

“In Part 111 ​(the federal rules governing GMPs for dietary supplements) you have to monitor for all potential contamination.  But Part 117 ​(FSMA) specifically talks about allergens,” ​she said.

Specific part of preventive controls program

Pavlick said identifying and controlling for allergens will form part of a company’s preventive controls program.  The four parts of this requirement are controlling for allergens, a sanitation control, a process control and a supply chain control. Allergens are a special category, not only because of the potential risk they pose to consumers, but because of how they are integrated into the final product.

“An allergen, once it’s in there, can’t be eliminated as part of your process. You can’t filter it out or cook it out,” ​Pavlick said.



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