June 13, 2012
MAITLAND, Fla.Caribe Natural LLC, an own-label distributor, received a warning letter from FDA outlining a number of cGMP (current good manufacturing practice) violations at the company's facility, illegal marketing claims the company made on it website and missing information on product labels.
Caribe Natural is an own-label distributor of the GERMA® brand of dietary supplements, meaning its products are made by contract manufacturers, but are marketed and distributed by Caribe Naturals. FDA was clear that this does not mean Cribe Nature does not have to follow GMPs.
"As an own-label distributor that contracts with other manufacturers to manufacture dietary supplements that your firm releases for distribution under your firms name, FDA considers you to be a manufacturer of such dietary supplements," Emma R. Singleton, Director of FDA's Florida District, wrote in the warning letter. " You have ultimate responsibility for the dietary supplements that you introduce or deliver for introduction into interstate commerce."
FDA inspected Caribe Natural from Sept. 6, to Nov. 23, 2011, and found several cGMP violations, according to the letter. FDA also noted that the company's response letter, sent in December 2011, inadequately addressed many of the issued FDA raised during the inspection.
GMP violations included:
Caribe Natural failed to make and keep written procedures for the responsibility of quality control (QC) operations. The agency found the company's response letter was inadequate because the company's QC procedures did not address responsibilities for returned products, or for rejecting packaged and labeled dietary supplements.
It did not keep written procedures for product complaints. FDA also found the company's response in this area to be lacking because it did not provide written procedures on how to investigate the complaint and how QC personnel will be involved in the review and approval process.
The company failed to measure the temperature or humidity levels in the product storage warehouse. Again, the company's response was inadequate, according to FDA, because the response did not establish written procedures for controlling and monitoring the temperature, humidity and light of the facility where finished and bulk products are stored.
Caribe Natural failed to make and keep written procedures for returned dietary supplements. The company's response was inadequate because its procedures did not include steps for identifying and quarantining returned dietary supplements until QC personnel conduct a review, and did not include procedures for when a returned dietary supplement may be salvaged.
It did have written procedures for holding and distributing operations. The company's response was inadequate because its procedures did not address holding dietary supplements under conditions that do not lead to the mix-up, contamination or deterioration of dietary supplements.
Caribe Natural failed to establish specifications to ensure the quality of dietary supplements and to ensure supplements are packaged and labeled as specified in the master manufacturing record (MMR).
It did not have specifications for each component used to manufacture its supplements.
The company did not have written MMR for each supplement formulation or for each batch size.
FDA also took a look at Caribe Natural's website and found some claims that put the company's products in the unapproved new drug classification. The site said the Colostrum A" Plus Dietary Supplement Helps to combat Virus and Bacteria," and said the UROBIOL With Nirurin product "Breaks kidney gallstones." Because these claims claim to treat and prevent disease, they are not considered dietary supplements, according to FDA in the warning letter.
FDA found a number of issues with several products labels, including:
Vigaril Natural Dietary Supplement and Germa 9 Syrup products list zinc gluconate, niacinamide and vitamin C , which have established daily reference intakes (DRIs), but are not declared in the proprietary blend in violation of the law. Statute requires the names of dietary ingredients that have daily values to be listed in a specified order and in a column display, while dietary ingredient that do not have daily values must be listed in a column or linear display.
The percent of the daily value must be declared for all dietary ingredients for which FDA has established daily values; however, Caribe Natural's Germa Malt Extract with Vitamins Reinforced by B-12 dietary supplement did not list the daily values for the ingredients.
The Vigaril Natural Stimulant dietary supplement product said contained ginseng, but the ginseng ingredient is not from a plant classified with the genus Panax. The product contains an ingredient identified as Siberian Ginseng (Eleutherococcus senticosus), but FDA said that ingredient may not be declared under a name that includes the term "ginseng" because it is not from the genus Panax. Himalayan Institute of Buffalo was also recently warned for this same violation.
Several products did not bear a domestic address or domestic phone number through which a person may receive a report of a serious adverse event.
Several product labels contained information in two languages, but do not repeat all the required information in both languages.
The Germa Colostrum A" Plus Dietary Supplement is fabricated from two or more ingredients, but the label fails to list the individual excipients; the label lists excipients," but fails to list the names of the individual excipients.
FDA gave Caribe Natural 15 working days to give it response to how it will fix the mentioned violation and how it will prevent them from happening again in the future.
Own-label distributers need to be sure they are following cGMPs even if they don't manufacturer their products themselves, including having written records and QC procedures. As Robin Koon explained in the INSIDER article, "Basic GMP Points to Consider," FDA expects own-label companies to have qualified their outsourced products, and have sufficient evidence to demonstrate and show GMP compliance. This warning letter backs up FDA's stance on this issue.
As noted in other warning letters, once FDA find violations from a facility, it will look elsewheresuch as the company website and labelsfor more violations. In this case, the agency found a few health claims that put products in the drug category and found a slew of problems with product labels. If FDA shows up for an inspection at a manufacturer's facility, it should be ready to have its claims and labels reviewed as well.
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