Health and Natural Beauty USA Corp.

Warning LetterOpen

Dr. Sayed Ibrahim President and Chief Executive Officer Health and Natural Beauty USA Corp. 140 Ethel Rd West, Ste W Piscataway , NJ 08854-5951 United StatesFEI 3011061274Issued Jul 28, 2025Center 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 3011061274.

Violations7

Issue DateJul 28, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: Health and Natural Beauty USA Corp.
Location: Dr. Sayed Ibrahim President and Chief Executive Officer Health and Natural Beauty USA Corp. 140 Ethel Rd West, Ste W Piscataway , NJ 08854-5951 United States
FEI Number: 3011061274
Country: United States
Issue Date: July 28, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Health and Natural Beauty USA Corp. was cited for significant Current Good Manufacturing Practice (CGMP) violations at its Piscataway, New Jersey facility during an October 2024 inspection, rendering its SprinJene oral healthcare products (including fluoride and children's toothpastes) adulterated under federal law. The company's SprinJene drug products were also found to be unapproved new drugs and misbranded, in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act. The FDA determined that the company's manufacturing methods, facilities, and controls failed to conform to CGMP regulations (21 CFR parts 210 and 211), and the company's November 2024 response to the FDA 483 inspection observations was deemed inadequate due to insufficient supporting documentation and corrective action evidence.

Health and Natural Beauty USA Corp. FDA Warning Letter, July 28, 2025