Warning letter signals return of on the ground inspection observations for 2022

By Hank Schultz

- Last updated on GMT

©Getty Images - Shidlovski
©Getty Images - Shidlovski

Related tags Dietary supplement companies Dietary supplement industry Fda regulations Gmps

A warning letter sent to a dietary supplement manufacturer signals a return of enforcement actions based on on-site inspections, which had been suspended for a time during the global pandemic.

The letter, which was addressed to Western Herb Products, Inc., of Index, WA, was the result of an on site inspection of the company’s facility that was conducted in May 2021.   The letter was dated Dec. 7 but was posted on FDA’s website at the end of December.

Most recent letters based on online investigations

Many warning letters posted in recent months have been the result of website reviews.  These have focused on impermissible disease claims which inspectors glean from the websites and social media platforms of dietary supplement marketers and manufacturers.

 Another big category of warning letters have focused on Foreign Supplier Verification Program compliance.  Larisa Pavlick, vice president of global regulatory and compliance for the United Natural Products Alliance and a former FDA inspector herself, said the industry should expect many more of these.  FSVP reviews can be triggered when materials cross the border, and the reviews are both straightforward and easy to conduct from the home offices of FDA personnel.  FSVP is one of the parts of FSMA, or the Food Safety Modernization Act, the provisions of which went into full gear for all sizes of companies several years ago.

But the old fashioned warning letter whose observations come from a knock on the door, boots on the ground kind of inspection?  That had vanished during the pandemic, but now seems poised for a comeback.

“It does seem like this is one of the first,”​ Pavlick told NutraIngredients-USA. “And this is a classic warning letter.  They have all of the top 10 citations mentioned in there.”

Company cited for testing, documentation deficiencies

FDA cited Western Herb for a laundry list of quality control and manufacturing deficiencies.  Among these was a lack of a robust  ID testing scheme for incoming raw material.   Western Herb was using microscopy as part of its ID process, but was not doing so in a scientifically valid manner, the Agency asserted.

Microscopy, along with organoleptic and macroscopic assessments, can be used as valid methods of identification when paired with the use of validated reference standards.  To be fully robust these should be paired with fit for purpose chemical analyses to create enough orthogonal data points for a complete picture.

But FDA says microscopy doesn’t work as an ID method when an attempt is made to extend it looking at materials once they’ve been pulverized, as Western Herb allegedly had done.

“Microscopic analyses may be an appropriate identity test for whole or coarsely cut botanical parts, but it may not be an appropriate identity test for powdered or extracted botanicals because of decreased reliability, or in those instances where misidentification of botanicals is known to occur,”​ the letter stated.

The physical characteristic of a plant significantly decreases as the plant is cut into a finer size or powder, as evidenced in the photos you provided,”​ the letter continued.

In addition to the testing issues, Western Herb was cited for a number of deficiencies in its manufacturing controls, including poorly constructed or missing standard operating procedures (SOPs) master manufacturing records  (MMRs) and batch production records (BPRs).  The company was also cited for deficiencies in its specifications and product ©G testing, and a lack of a procedure for collecting complaints from consumers. 

Western Herb declined to comment on the warning letter when contacted by NutraIngredients-USA.

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