AmWiner & Raphe Holdings, LLC dba rapheGenerics Corp

Warning LetterOpen

Ms. Ijyahu Raphe Eze Owner AmWiner & Raphe Holdings, LLC dba rapheGenerics Corp 802 East Walnut Street Garland , TX 75040 United StatesFEI 3009569638Issued Jan 29, 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 3009569638.

Violations6

Issue DateJan 29, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: AmWiner & Raphe Holdings, LLC dba rapheGenerics Corp
Location: Ms. Ijyahu Raphe Eze Owner AmWiner & Raphe Holdings, LLC dba rapheGenerics Corp 802 East Walnut Street Garland , TX 75040 United States
FEI Number: 3009569638
Country: United States
Issue Date: January 29, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

AmWiner & Raphe Holdings, LLC dba rapheGenerics Corp, a drug manufacturer in Dallas, Texas, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals during an FDA inspection from June to August 2024. The company failed to establish adequate laboratory testing procedures and release specifications for its over-the-counter topical drug products containing minoxidil before distributing them to market, resulting in adulterated drugs. Additionally, two hair restoration products—"Men's Lifecell Hair Restoration Solution Hair Regrowth Treatment Extra Strength" and "Women's Lifecell 2% Minoxidil Topical Solution USP Hair Regrowth Treatment"—were distributed as unapproved new drugs in violation of federal law.

AmWiner & Raphe Holdings, LLC dba rapheGenerics Corp FDA Warning Letter, January 29, 2025