• Login
    • Join
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Formulary
    • Exclusives
    • Top Companies
    • Raw Materials
    • End-User
    • Packaging
    • Directories
    • Events
    • Jobs
    • More
  • Magazine
  • News
  • Formulary
  • Exclusives
  • Top Companies
  • Raw Materials
  • End-User
  • Packaging
  • Directories
  • Events
  • Jobs
  • Current / Back Issues
    Features
    Columns
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Subscribe Now
    Advertise Now
    Top Features
    Shape Up!

    Connecting To The Consumer

    Enhancing Cosmeceuticals Via Phytonutrients

    Building on Its Strength

    Pardon the Disruption
    Online Exclusives
    Association News
    Breaking News
    Financial News
    Industry News
    International
    Marketing News
    New Products
    News Front
    Packaging News
    Patents
    Personnel
    Regulations
    Snapshots
    Top News
    Live From Shows
    Top News
    Charkit Names Lang President

    Kline Takes Deep Dive into HI&I

    Burt's Bees To Present Rosacea Data at AAD Meeting

    Makeup Sales Rise for Valentine’s Day

    Valmont Celebrates Art
    Blog
    Online Exclusives
    Infographics
    Podcasts
    Whitepapers
    Videos
    Expert's Opinion
    Surveys
    International Top 30 Report
    Top 50 Report
    Top Companies
    26. McBride plc

    49. Murad

    16. Rodan + Fields

    20. Boticário Group

    32. Prestige Brands
    Actives
    Functional Ingredients
    Pigments
    Polymers
    Preservatives
    Surfactants

    Kline Takes Deep Dive into HI&I

    ACI Cleans Up in Orlando

    A Thing of Beauty in Panama

    Kiehl's Launches Cannabis Sativa Seed Facial Oil

    Croda Supports Panama Beauty Project
    Air Care/Environmental Fragrance
    AP/Deo
    Color Cosmetics
    Disinfectants
    Fine Fragrance
    Hair Care
    Household Cleaning
    I&I Marketplace
    Laundry Care
    Oral Care
    OTC/Medicated
    Packaging
    Personal Cleansers
    Skin Care
    Sun Care
    Testing

    Kline Takes Deep Dive into HI&I

    Burt's Bees To Present Rosacea Data at AAD Meeting

    ACI Cleans Up in Orlando

    Clairol Rolls Out New Color Blending Gel

    Moberg Pharma Sells OTC Business
    Lab Equipment
    Mixing
    Packaging
    Testing

    Method Unveils Spring Limited Edition Line

    More Eco Options Roll Out in Laundry Space

    The Art of Working with Artists

    Lush Gets Naked

    Henkel, P&G Founding Members of New Alliance to End Plastic Waste
    Contract Manufacturing / Private Label Directory
    Buyer's Guide
    Add New Company
    Corporate Profiles
    International Buyers Guide Companies
    CIE

    Siltech Corporation

    Sabinsa Cosmetics, a division of Sabinsa Corporation

    Ashland

    Croda
    Live From Shows
    Meetings
    Webinars
    Snapshots
    • Magazine
      • Current / Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Edition
      • eNewsletter Archive
      • Subscribe Now
      • Advertise Now
    • Breaking News
    • Formulary
    • Directories
      • Buyer's Guide
      • Contract Manufacturing / Private Label Directory
      • Corporate Profiles
      • Add Your Company
    • Raw Materials
      • Actives
      • Functional Ingredients
      • Pigments
      • Polymers
      • Preservatives
      • Surfactants
    • End-User
      • Air Care/Environmental Fragrance
      • AP/Deo
      • Color Cosmetics
      • Disinfectants
      • Fine Fragrance
      • Hair Care
      • Household Cleaning
      • I&I Marketplace
      • Laundry Care
      • Oral Care
      • OTC/Medicated
      • Packaging
      • Personal Cleansers
      • Skin Care
      • Sun Care
      • Testing
    • Packaging
      • Lab Equipment
      • Mixing
      • Packaging
      • Testing
    • Top Companies
      • International Top 30 Report
      • Top 50 Report
    • Online Exclusives
    • Experts Opinion
    • Slideshows
    • Videos
    • Podcasts
    • Infographics
    • Blog
    • Whitepapers
    • Surveys
      • R & D Salary Survey
      • Sales & Marketing Salary Survey
    • Job Banks
    • Events
      • Industry Events
      • Live from show Events
      • Webinars
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Breaking News

    FDA Issues Letter to Soleo of Korea

    Agency outlines issues with drug claims and more.

    Related CONTENT
    • Northern Labs, Inc.
    • Medical Devices for the Cosmetic Endpoint
    • Testing, Testing
    • OTC Sunscreen Filters Are on Life Support
    • Where Cosmetics & Pharma Meet
    02.06.19
     The US Food and Drug Administration (FDA) has sent a warning letter to Ji Hyun Min, CEO of Soleo of Korea. FDA conducted an inspection of the company’s drug manufacturing facility from August 6 to 9, 2018. The warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.
     
    Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351(a)(2)(B)).
     
    In addition, as formulated and labeled, “Gen+Le Therapy Shampoo” is an unapproved new drug in violation of section 505(a) of the FD&C Act (21 U.S.C. 355(a)). Introduction of such a product into interstate commerce is prohibited under section 301(d) of the FD&C Act (21 U.S.C. 331(d)).
     
    During the inspection, the FDA investigator observed specific violations.

    For example, Sole failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and (2)).
     
    According to FDA, the company lacked testing of incoming raw materials, including active pharmaceutical ingredients and components, used in manufacturing of your Gentle Therapy Shampoo over-the-counter (OTC) drug product, for their identity, strength, and other appropriate quality attributes. Instead, your firm relied solely on your suppliers’ certificates of analysis (COA) without establishing the reliability of the suppliers’ analyses through appropriate validation.
     
    FDA said it reviewed the company’s August 23, 2018 response in detail, in which Soleo said it would “ try to proceed by purchasing the experimental equipment also so that we [Soleo] can directly analyze the ingredients contained in the raw material”.
     
    FDA called the company’s response inadequate because it failed to provide a detailed procedure for conducting raw material testing, a target date for implementation, and a plan of action in the interim.
     
    In response to this letter, FDA has asked the company to provide:

    • Chemical and microbiological quality control specifications you will use to approve the release of each incoming lot of components for use in manufacturing.
    • A description of how you will conduct at least one specific identity test for each incoming component lot, regardless of a COA validation program
    • A description of how you will test each component lot for conformity with all appropriate specifications for strength, quality, and purity. If you intend to accept any testing results from your supplier’s COA in lieu of your testing of each component lot for purity, strength, and quality, specify how you plan to establish the reliability and consistency of your supplier’s test results for these attributes through initial validation (followed by periodic re-validation). Include your standard operating procedure that describes this COA validation program.

    A summary of test results obtained from full testing of reserves samples of active pharmaceutical ingredient lots used in the manufacture of your drug product that were distributed to the U.S. market and within expiry.

    • A comprehensive independent review of your material system to determine whether all containers, closures, and ingredients from each supplier are adequately qualified and are assigned appropriate expiration or retest dates. Also determine whether your controls for incoming material lots are adequate to prevent the use of unsuitable containers, closures, and components.
     
    FDA said Soleo failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)).
     
    FDA also said Soleo failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).
     
    FDA also contends Soleo failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).
     
    Based upon the nature of the violations identified, FDA said it strongly recommends engaging a consultant, qualified as set forth in 21 CFR 211.34, to evaluate your operations and assist your firm in meeting CGMP requirements. “We also recommend that the qualified consultant perform a comprehensive audit of your entire operation for CGMP compliance and evaluate the completion and effectiveness of any corrective action and preventative action plan you have implemented,” FDA penned in its letter.
     
    Examples of claims observed on Soleo’s product label, and on its labeling which includes your product website for “GEN+LE THERAPY Shampoo” that establish the intended uses of the product as defined in 21 CFR 201.128 include, but may not be limited to, the following:
    ·       Label Claims:
    “Prevents Hair Loss ... Hair Loss Prevention ... Anti-Dandruff”
    ·       Website Claims:
    “Is your dandruff out of control? The solution is GEN+LE THERAPY SHAMPOO & TREATEMENT ... Anti-Dandruff ... A inveterate Dandruff goes away in a short time ... Hair Loss Prevention ... Biotin helps your hair grow ...”
     
    Based on the above claims, “GEN+LE THERAPY Shampoo” is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act (21 U.S.C. 321(g)(1)(B)) because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act (21 U.S.C. 321(g)(1)(C)) because it is intended to affect the structure or any function of the body. Specifically, this product is intended as a hair growth, hair loss prevention, and anti-dandruff drug product. 
     
    Under 21 CFR 310.527, OTC drug products intended as an external hair grower, such as “GEN+LE THERAPY Shampoo”, that are labeled, represented, or promoted for external use as a hair grower or for hair loss prevention are regarded as new drugs within the meaning of section 201(p) of the FD&C Act and require an FDA-approved application prior to being marketed.
     
    In addition, drug products intended for the treatment of dandruff, such as “GEN+LE THERAPY Shampoo” are subject to the Final Rule for Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis (21 CFR 358, Subpart H). However, the formulation for “GEN+LE THERAPY Shampoo” is not consistent with the formulation requirements that describe acceptable active ingredients for drug products for the treatment of dandruff. Specifically, biotin, niacinamide, and dexpanthenol do not comply with the acceptable active ingredients in 21 CFR 358.710.
     
    Thus, as formulated and labeled, “GEN+LE THERAPY Shampoo” does not comply with the final rules described above. Furthermore, we are not aware of sufficient evidence to show that “GEN+LE THERAPY Shampoo”, as formulated and labeled, is generally recognized as safe and effective. Therefore, this product is a new drug within the meaning of section 201(p) of the FD&C Act (21 U.S.C. 321(p)). As a new drug, “GEN+LE THERAPY Shampoo” may not be legally marketed in the United States absent approval of an application filed in accordance with section 505(a) of the FD&C Act (21 U.S.C. 355(a)). “GEN+LE THERAPY Shampoo” is not the subject of an FDA-approved application and therefore, the current marketing of this product violates section 505(a) of the FD&C Act (21 U.S.C. 355(a)). Introduction of such products into interstate commerce is prohibited under section 301(d) of the FD&C Act (21 U.S.C. 331(d)).
     
    FDA placed the firm on Import Alert 66-40 on November 26, 2018, and indicated that until Soelo corrects all violations completely and FDA confirms compliance with CGMP, it may withhold approval of any new applications or supplements listing your firm as a drug manufacturer.
     
    Failure to correct these violations may also result in FDA continuing to refuse admission of articles manufactured at Soleo at 24 Sandan-Ro, Pyeongtaek-Si, Gyeonggi-do, into the United States under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)). Under the same authority, articles may be subject to refusal of admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)), said FDA.
    Related Searches
    • approved
    • fda
    • drug
    • suppliers
    Related Knowledge Center
    • Hair Care
    Suggested For You
    ACI Approves FDA Proposal for Food Handler Antiseptics ACI Approves FDA Proposal for Food Handler Antiseptics
    Hemp Declassification To Light Up CBD Market Hemp Declassification To Light Up CBD Market
    Prospects for Cosmeceuticals Dim in China Prospects for Cosmeceuticals Dim in China
    FDA Issues RFI on Food Handler Antiseptics FDA Issues RFI on Food Handler Antiseptics
    ACI Welcomes New FDA Rulemaking for Food Handler Antiseptics ACI Welcomes New FDA Rulemaking for Food Handler Antiseptics
    FDA Issues RFI on OTC Food Handler Antiseptics FDA Issues RFI on OTC Food Handler Antiseptics
    Surf’s Up: Hawaii Makes Waves  With Ban of Sunscreen Filters Surf’s Up: Hawaii Makes Waves With Ban of Sunscreen Filters
    Demand for Acne Treatment Rises Demand for Acne Treatment Rises
    FDA Seeks Comments on Proposed Consumer Survey about Allergens in Cosmetics FDA Seeks Comments on Proposed Consumer Survey about Allergens in Cosmetics
    Verify then Trust Verify then Trust
    Tennessee Skin/Haircare Company Ordered To Halt Operations Tennessee Skin/Haircare Company Ordered To Halt Operations
    Cap It Off! Cap It Off!
    Where Cosmetics & Pharma Meet Where Cosmetics & Pharma Meet
    OTC Sunscreen Filters Are on Life Support OTC Sunscreen Filters Are on Life Support
    Testing, Testing Testing, Testing

    Related Breaking News

    • Hair Care
      Clairol Rolls Out New Color Blending Gel

      Clairol Rolls Out New Color Blending Gel

      Solution between one-wash temporary solutions and permanent root touch-ups.
      02.12.19

    • Color Cosmetics | Fine Fragrance | Hair Care | Skin Care
      JAB Makes Tender Offer for Additional Coty Shares

      JAB Makes Tender Offer for Additional Coty Shares

      Offers $11.65 per share.
      02.12.19

    • Actives | Color Cosmetics | Functional Ingredients | Hair Care | Oral Care | Preservatives | Skin Care

      Schülke Ingredients Are Halal Certified

      Entire portfolio of personal care products meets all requirements.
      02.11.19


    • Hair Care | Skin Care

      Jojoba Desert Opens US Subsidiary

      Industry veteran Angela Medina is named business development director, USA and Canada.
      02.11.19

    • Actives | Color Cosmetics | Functional Ingredients | Hair Care | Personal Cleansers | Pigments | Skin Care | Sun Care | Surfactants
      Croda Supports Panama Beauty Project

      Croda Supports Panama Beauty Project

      Helping to change the lives of women and children through this initiative that begins today.
      02.07.19

    • Hair Care | Household Cleaning | Laundry Care | Personal Cleansers | Skin Care | Surfactants
      Surfactant Congress Seeks Posters

      Surfactant Congress Seeks Posters

      CESIO submission deadline is Feb. 15, 2019.
      02.05.19


    • Hair Care | Personal Cleansers | Skin Care

      L'Occitane and Loop Industries Sign Supply Accord

      Incorporating branded PET into beauty brand's packaging.
      02.04.19

    • Hair Care

      ELC Appoints Garrison as SVP

      Estée Lauder Companies: Amber Garrison was named senior vice president, global general manager, Bumble and bumble. She reports directly to Jane Hertzmark Hudis, group president, and will join the company’s extended executive leadership t…
      02.01.19

    • Hair Care

      Schaeffler Is CEO at DevaCurl

      DevaCurl: named Robert Schaeffler as CEO. DevaCurl is a portfolio company of the private equity group of Ares Management, LP.  In his new role, Schaeffler is poised to strengthen DevaCurl’s position as a leading curly hair brand. He will f…
      02.01.19


    • Functional Ingredients | Hair Care | Personal Cleansers | Skin Care

      Harris Is Vantage Specialties CEO

      Vantage Specialties, Inc.: welcomed Andy Harris as CEO. He also joins Vantage’s board of directors and is an equity investor alongside H.I.G. Capital, LLC in the company. Most recently, Harris was the CEO of Accella Performance Materials. Du…
      02.01.19

    • Color Cosmetics | Hair Care | Skin Care

      L’Oréal Promotes Babule to CFO

      L’Oréal: named Christophe Babule as its new executive vice president, chief financial officer and member of L’Oréal’s executive committee as of mid-February 2019. He succeeds Christian Mulliez who, after 17 years as ex…
      02.01.19

    • Color Cosmetics | Hair Care | Skin Care

      Mana Products’ Nikos Mouyiaris Dies

      Mana Products founder Nikos Mouyiaris has died. An immigrant from Cyprus, Mouyiaris studied chemical engineering at Rutgers University and St. John’s University before founding Mana Products Inc., a leading contract and private label manufactur…
      02.01.19

    • Hair Care | Skin Care

      Nerium Is Now Neora

      Nerium International, Addison, TX, is changing its name to Neora as part of a global rebrand that it contends reflects the company’s evolution as both a relationship marketer and vision as an anti-aging industry leader. The transition was plann…
      02.01.19

    • Hair Care | Household Cleaning | Laundry Care | Oral Care | Skin Care

      Procter & Gamble Named a ‘Just’ Company

      The Procter & Gamble Company has been recognized as the eighth Most “Just” Company in America and first among personal care companies, according to Forbes and Just Capital, a nonprofit that ranks the largest publicly traded corporatio…
      02.01.19

    • Hair Care | Pigments

      Silver Strands Shine with Redken

      Redken rolled out a new color care line specifically formulated for naturally gray and silver hair. Redken Color Extend Graydiant! Redken Color Extend Graydiant Shampoo is an anti-yellow, color-depositing shampoo that, along with the Silver Condit…
      02.01.19

    Breaking News
    • Charkit Names Lang President
    • Kline Takes Deep Dive into HI&I
    • Burt's Bees To Present Rosacea Data at AAD Meeting
    • Growing Demand for Moss-Based Cosmetics
    • HCPA Calls for PRIA Authorization
    View Breaking News >
    CURRENT ISSUE

    February 2019

    • Shape Up!
    • Connecting To The Consumer
    • Enhancing Cosmeceuticals Via Phytonutrients
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • privacy policy
    • term and condition
    • about us
    • contact us

    follow us

    Subscribe

    magazines

    Image
    Image
    Image
    Image
    Image
    Image
    Image
    Image
    Image
    Image
    Image

    Copyright © 2019 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login