Sambrosa Care Inc.

Warning LetterOpen

John F.R. de Wit, Pharm.D. Sambrosa Care Inc. 9171 Wilshire Boulevard Suite 500 Beverly Hills , CA 90210 United States john@dromenwinkel.com john@sambrosacare.comFEI 3018095920Issued Jan 24, 2024Center for Drug Evaluation and Research | CDER

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3018095920.

Violations3

Issue DateJan 24, 2024

Product TypeDrugs

StatusOpen

Letter Details

Firm: Sambrosa Care Inc.
Location: John F.R. de Wit, Pharm.D. Sambrosa Care Inc. 9171 Wilshire Boulevard Suite 500 Beverly Hills , CA 90210 United States john@dromenwinkel.com john@sambrosacare.com
FEI Number: 3018095920
Country: United States
Issue Date: January 24, 2024
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Sambrosa Care Inc. distributed an unapproved over-the-counter drug product called "Sambrosa sweet dreams Night Syrup," a combination antihistamine and nighttime sleep-aid, in violation of federal law requiring new drug approval before marketing. The product violated section 505(a) of the FD&C Act by being introduced into interstate commerce without approval and was misbranded under section 502(ee), with marketing claims on the company's website and product labeling establishing its intended use as a drug for treating allergy symptoms and promoting sleep. The company marketed and sold the product through its website at sambrosa.com without obtaining the required FDA approval for this combination drug formulation.

Sambrosa Care Inc. FDA Warning Letter, January 24, 2024