Florida firm accused of serious cGMP violations and unauthorized disease claims

By Elaine Watson

- Last updated on GMT

Florida firm accused of serious cGMP violations and drug claims
Private label supplement distributor Caribe Natural has been warned by the FDA that it is still responsible for violations of current Good Manufacturing Practice (cGMP) regulations and making drug claims on product labels, even though its supplements are made by third parties.

In a warning letter mailed to the Miami, Florida-based firm last month, the FDA said bosses had “informed our investigators that your firm is an own-label distributor of your GERMA brand dietary supplements that has entered into agreements with contract manufacturers to manufacture your dietary supplements”.

It added: “As an own-label distributor that contracts with other manufacturers to manufacture dietary supplements that your firm releases for distribution under your firm’s name, FDA considers you to be a manufacturer of such dietary supplements.

“You have ultimate responsibility for the dietary supplements that you introduce or deliver for introduction into interstate commerce.”

Serious violations of cGMP regs

An inspection last fall had revealed serious violations of cGMP regulations, said the FDA, notably that Caribe had not maintained proper records of its quality controls and product complaint procedures.

It had also failed to hold ingredients and finished supplements “under appropriate conditions of temperature, humidity, and light so that the identity, purity, strength, and composition of the components and dietary supplements are not affected”.

It added: “Specifically, you informed our investigators that you do not measure the temperature or humidity levels in your product storage warehouse.”

It also failed to make and keep written procedures for handling returned supplements, and failed to establish proper specifications either for raw materials or finished products according to master manufacturing records.

Unapproved New Drugs

Separately, Caribe was making unauthorized drug claims that its Colostrum ‘A’ Plus (pictured) and Urobiol supplements could cure, mitigate, treat, or prevent disease, claimed the FDA.

It also alerted the company to several labeling errors on its Vigaril Natural Stimulant dietary supplement:

“The purported 'ginseng' ingredient​ [in the Vigaril supplement] is not from a plant classified with the genus Panax… the term ‘ginseng’ may only be considered to be a common or usual name (or part thereof) for any herb or herbal ingredient derived from a plant classified within the genus Panax.

"Your product contains an ingredient identified as Siberian Ginseng (Eleutherococcus senticosus). That ingredient may not be declared under a name that includes the term 'ginseng' because it is not from the genus Panax."

Caribe Natural did not respond to requests for comment before this article went to press.

Related topics: Regulation, GMPs, QA & QC, Product claims

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