Aqualex Co., Ltd.
FDA issued a warning letter to Aqualex Co., Ltd., a South Korean OTC sunscreen drug manufacturer, citing multiple CGMP violations (process validation, water system design, quality unit failures, inadequate release and stability testing) and declaring their 'DBH Beverly Hills, EGF FGF DNA, UV Shield' product an unapproved new drug. The product's website marketing claims for EGF, FGF, and DNA ingredients as anti-aging and cell-repair actives rendered them unapproved active ingredients outside the OTC sunscreen monograph. The product was also found misbranded for contradictory labeling (claiming 'OCTINOXATE FREE' while listing octinoxate as an active ingredient), missing manufacturer identity, and use of non-established ingredient names. FDA placed the firm on Import Alert 66-40 and required a written response within 15 working days.
Flagged claims (5)
OCTINOXATE FREE
DBH Beverly Hills, EGF FGF DNA, UV Shield . . . UVA UVB Sunscreen Protection . . . DRUG FACTS . . . Uses -Helps prevent sunburn – If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun . . .
New Advanced Formula with EFG, FGF, and DNA growth factors – active anti-aging peptides to help repair sun damage!
BREAKTHROUGH INGREDIENTS . . . Cell Renewal – Sh-Oligopeptide-1 (EFG), Advanced defense against aging and cell damage . . . Cell Growth – Sr-Rainbow Trout Oligopeptide-1 (FGF), Multi-chain amino acids for deeper nutrient delivery . . . Cell Health – Sodium Deoxyribonucleic Acid (DNA), Boost cellular recovery and rehabilitation
WHY JUST PROTECT WHEN YOU CAN CORRECT AT THE SAME TIME? . . . the UV Shield: EFG FGF DNA sun protection is formulated with epidermal growth factors (EGF) for multi-active defense against aging and cell damage, Fibroblast Growth Factors (FGF) for multi-chain amino acid and nutrient delivery throughout the skin layers, and Sodium Deoxyribonucleic acid (DNA) for cell recovery and rehabilitation. . . .
Required actions (5)
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence.
FDA placed your firm on Import Alert 66-40 on February 9, 2024.
Until FDA is permitted to inspect your facility and confirms compliance with CGMP, we may withhold approval of any new applications or supplements listing your firm as a drug manufacturer.
shipments of articles manufactured at Aqualex Co., Ltd., FEI 3010683345, at RM 203, 27, Dunchon-daero 457beon-gil into the United States that appear to be adulterated or misbranded are subject to being detained or refused admission pursuant to section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3).
We may re-inspect to verify that you have completed corrective actions to any violations.
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