• 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
    A Conversation with the Responsible Flushing Alliance

    Nice-Pak Meets Consumer Demands

    Wipes Manufacturers Meet Demand Surge

    Home Care Wipes: Sustainability in Sharper Focus as Cleaning Frenzy Simmers Following Pandemic

    The Cannabis Glow Up
    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
    TFF Names 2021 Honorees for Lifetime Achievement Perfumer and Hall of Fame

    Ashland Donates $20,000 To Help Plant Trees

    Multi-Purpose Sustainable 'Just Add Water' Household Cleaner Expands Cleaning Products

    Kao Launches Oribe in Japan

    Love Beauty and Planet Shares Sustainability Initiatives With Refillable Hair Care at Target
    Blog
    Online Exclusives
    Infographics
    Podcasts
    Whitepapers
    Videos
    Expert's Opinion
    HappiTV
    eBook
    Surveys
    International Top 30 Report
    Top 50 Report
    Top Companies
    44. Gojo

    32. Inter Parfums

    32. WD-40 Company

    The International Top 30 Report

    4. Henkel
    Actives
    Functional Ingredients
    Pigments
    Polymers
    Preservatives
    Surfactants

    The Estée Lauder Companies Is Beauty Inspired, Values Driven

    HCPA Mid-Year Meeting Adds Keynote

    CP Kelco's Progress Toward 2022 Sustainability Objectives

    Ball Care, a New Category in Men’s Grooming

    Jeen International Celebrates Its 25th Anniversary
    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

    TFF Names 2021 Honorees for Lifetime Achievement Perfumer and Hall of Fame

    The Estée Lauder Companies Is Beauty Inspired, Values Driven

    Multi-Purpose Sustainable 'Just Add Water' Household Cleaner Expands Cleaning Products

    No H20: The Rising Tide of Waterless Beauty

    Kao Launches Oribe in Japan
    Lab Equipment
    Mixing
    Packaging
    Testing

    Pact Collective Is New Non-Profit Recycling Take-Back Program for Beauty

    New Beauty Brand sk*p Wants to Break Addiction to Plastic

    Arbonne's One Year Anniversary as a B Corp

    Admix Appoints COO to Advance Manufacturing, Supply Chain & Regulatory Compliance

    Tesco Eliminates Plastic Bags from Online Orders
    Contract Manufacturing / Private Label Directory
    Buyer's Guide
    Add New Company
    Corporate Profiles
    International Buyers Guide Companies
    BotanicalsPlus

    QRS (Quality Resourcing Services)

    Centerchem Inc

    Baralan USA

    Resolute Oil
    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
    • HappiTV
    • Videos
    • Podcasts
    • eBook
    • 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

    Chinese Wipes Maker Flagged by FDA

    Cited for violations at production facility making antibacterial wipes for US market.

    Related CONTENT
    • LEO Pharma and Bayer Complete Rx Derm Transfer
    • 45. Spartan Chemical Company
    • New FDA Warning Letters
    • FDA on CBD
    • A Better Mousetrap
    07.03.19
    Xi’an Livingbond Nonwoven Products Corp., Ltd., China, has been issued a warning letter by the US FDAfollowing an inspection of its drug manufacturing facility at Fengjing Ind Park, Hu District, Xian Shaanxi from January 7-10, 2019, where product such as antibacterial wet wipes are produced for the US market.

    FDA says it found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211. 

    Based on FDA review, the company’s products, Antibacterial Wet Wipes (in four separate package configurations) are also misbranded under section 502(x) of the FD&C Act, 21 U.S.C. 352(x). Introduction of such products into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

    The inspection found that the company did not test its over-the-counter (OTC) finished drug products to determine whether each batch meets identity and strength specifications before releasing those products to the U.S. market.

    In addition, the firm lacked reliable testing for microbial attributes. For example, FDA said the company did not have an adequate program for growth promotion testing of media used for microbial testing. 
    FDA said that that in its response, the firm  stated that it will send each finished product batch to a third party to test for active ingredient identity and strength prior to release, and that it also stated plans to purchase a chromatographic analyzer.  

    “We acknowledge your commitment to perform growth promotion test on each batch of media to assure the reliability of the microbiological results,” penned FDA in its letter. However it said,the response is “inadequate because it did not commit to take any corrective action for products already in the market, include information about your third-party testing laboratory, or provide procedures to be used for additional testing. You must ensure each batch of your drug products meets all chemical and microbiological specifications before release.”

    FDA has asked the firm provide:
    ·      A list of all chemical and microbial test methods and specifications used to analyze each batch of your drug products before making the batch disposition decision, and associated written procedures. 
    ·      A summary of test results obtained from retrospective testing of retain samples of all drug product batches currently in distribution in the United States. Include test results for identity and strength of active ingredients, and all other appropriate chemical and microbial quality attributes. If you released any batch that was out of specification, indicate the corrective action you will take, such as customer notifications and product recalls. 
    ·      A comprehensive and independent review of your laboratory practices, procedures, methods, equipment and analyst competencies. Based on this review, provide a detailed corrective action and preventive action (CAPA) plan to fully remediate your laboratory system. Your plan should also include the procedures you will use to evaluate the effectiveness of the implemented CAPA.
    ·      Provide your procedure to assure that any test methods performed by a contract testing laboratory on your behalf are properly transferred and validated before use. 
     
    Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant qualified as set forth in 21 CFR 211.34 to 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 that the consultant evaluates the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA. 
     
    Antibacterial Wet Wipes are “drugs” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease and/or as defined under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body. Specifically, these products are intended as consumer antiseptic rubs.
       
    FDA placed the company on Import Alert 66-40 on April 12, 2019. 

    Until Xi’an Livingbond Nonwoven Products Corp correct sall violations completely and FDA confirms compliance with CGMP, the agency may withhold approval of any new applications or supplements listing your firm as a drug manufacturer. 
    Related Searches
    • contract
    • it
    • active
    • testing
    Related Knowledge Center
    • OTC/Medicated
    Suggested For You
    LEO Pharma and Bayer Complete Rx Derm Transfer LEO Pharma and Bayer Complete Rx Derm Transfer
    45. Spartan Chemical Company 45. Spartan Chemical Company
    New FDA Warning Letters New FDA Warning Letters
    FDA on CBD FDA on CBD
    A Better Mousetrap A Better Mousetrap
    Beiersdorf Buys Coppertone Beiersdorf Buys Coppertone
    FDA Puts Hold on Repeal of Lead Acetate in Hair Dyes FDA Puts Hold on Repeal of Lead Acetate in Hair Dyes
    FDA Sends Warning Letter to Laboratoires Clarins FDA Sends Warning Letter to Laboratoires Clarins
    Bayer Sells Coppertone Bayer Sells Coppertone
    FDA Hosting Public Meeting To Prep for ICCR-13 FDA Hosting Public Meeting To Prep for ICCR-13
    A World of Opportunities To Help Others A World of Opportunities To Help Others
    FDA Puts Hold on Repeal of Lead Acetate in Hair Dyes FDA Puts Hold on Repeal of Lead Acetate in Hair Dyes
    FDA Sends Warning Letter To Topical Pain Treatment Maker FDA Sends Warning Letter To Topical Pain Treatment Maker
    Asbestos? In Cosmetics? Asbestos? In Cosmetics?
    Read FDA Read FDA's Statement on Cosmetics Safety

    Related Breaking News

    • OTC/Medicated
      OTC Pain Relief QR Cream Debuts in US Market

      OTC Pain Relief QR Cream Debuts in US Market

      Mannitol is the key ingredient in this cream sold on Amazon.
      Charles Sternberg, Assistant Editor 04.13.21

    • OTC/Medicated
      FDA Shares Updated OTC Drug Fees

      FDA Shares Updated OTC Drug Fees

      Facility fees for FY2021 are due on May 10, 2021.
      Melissa Meisel, Associate Editor 04.06.21

    • OTC/Medicated
      FDA Warns Firms Illegally Selling OTC CBD Topicals for Pain Relief

      FDA Warns Firms Illegally Selling OTC CBD Topicals for Pain Relief

      Products listing CBD as inactive ingredient cited for unapproved drug and misbranding violations.
      Christine Esposito, Managing Editor 03.22.21


    • OTC/Medicated | Skin Care
      PanOxyl Acne Face Wash Rises in The Ranks

      PanOxyl Acne Face Wash Rises in The Ranks

      Crown Therapeutics OTC formulation is fueled by 10% benzoyl peroxide.
      Christine Esposito, Managing Editor 03.18.21

    • OTC/Medicated | Skin Care
      Indena Becomes First Italian Company Authorized to Produce CBD

      Indena Becomes First Italian Company Authorized to Produce CBD

      Receives authorization from the Ministry of Health and Italian Medicines Agency.
      Charles Sternberg, Assistant Editor 03.01.21

    • OTC/Medicated
      J.R. Watkins Tackles Pain with New Lines

      J.R. Watkins Tackles Pain with New Lines

      Sprays, lotions and roll-on formats.
      Christine Esposito, Managing Editor 02.24.21


    • OTC/Medicated
      Unilever Gets Welly

      Unilever Gets Welly

      Acquires colorful, first-aid brand from Eric Ryan.
      Tom Branna , Editorial Director 02.10.21

    • Functional Ingredients | OTC/Medicated
      CBD Brand Raises $5 Million

      CBD Brand Raises $5 Million

      Boston-based Beam expands into hydration category, too.
      Tom Branna, Editorial Director 02.09.21

    • Actives | OTC/Medicated | Skin Care
      Isosorbide Di-(Linoleate/Oleate) Treats Xerotic Pruritic Skin

      Isosorbide Di-(Linoleate/Oleate) Treats Xerotic Pruritic Skin

      Sytheon publishes study in the Journal of Investigative Dermatology.
      Happi Staff 01.14.21


    • OTC/Medicated | Skin Care
      Minority Investment for Hero Cosmetics

      Minority Investment for Hero Cosmetics

      Fast-growing acne patch maker's first outside capital.
      Happi Staff 01.12.21

    • OTC/Medicated
      The Next Normal

      The Next Normal

      Trends to watch post-COVID, according to McKinsey.
      Happi Staff 01.10.21

    • OTC/Medicated | Skin Care

      Topical Homeopathic Formulation

      Actives portion of this formulation contains Arnica Montana and myriad materials.
      Happi Staff 12.31.20


    • Actives | Functional Ingredients | OTC/Medicated | Skin Care | Sun Care
      J&J Seeks Black Innovators in Skin Care

      J&J Seeks Black Innovators in Skin Care

      Johnson & Johnson issues QuickFire Challenge
      Happi Staff 12.01.20

    • OTC/Medicated

      Topical Pain Relief

      Connecticut company patents transdermal ibuprofen composition.
      11.25.20

    • OTC/Medicated
      NAD Rules on Kerasal Fungal Nail Treatment

      NAD Rules on Kerasal Fungal Nail Treatment

      Supports discoloration claim, recommends discontinuing others.
      Happi Staff 11.04.20

    Trending
    • Sunscreen On The Spot
    • It's Official! L'Oréal Gets New CEO On May 1
    • Clinique’s #ZitHappens TikTok Challenge Celebrates ‘Skin Positivity’
    • BASF Increases Price Of Kaolin
    • K18 Biomimetic Hairscience Debuts In Salons
    Breaking News
    • L’Oréal Successfully Defends Itself In Patent Infringement Lawsuit
    • TFF Names 2021 Honorees for Lifetime Achievement Perfumer and Hall of Fame
    • Ashland Donates $20,000 To Help Plant Trees
    • Multi-Purpose Sustainable 'Just Add Water' Household Cleaner Expands Cleaning Products
    • Kao Launches Oribe in Japan
    View Breaking News >
    CURRENT ISSUE

    CBD Inside & Out

    • The Cannabis Glow Up
    • Mary Jane's Botanicals
    • A Closer Look at cbdMD
    • Is Cannabidiol Coming to Your City or Hamlet?
    • USDA's Final Rule on Hemp
    • A CBD Packaging Evolution
    • CBD Food & Supplement Market Is in Limbo
    • CBD New Product Development
    • 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”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Ashland Supports the Nature Conservancy Forest Restoration Effort to Help Plant a Billion Trees
    Martin Bauer Announces Installation of Agile Filling System at Bethlehem, PA Facility
    PepsiCo and Ingredion Begin Pilot Partnership with Soil and Water Outcomes Fund
    Coatings World

    Latest Breaking News From Coatings World

    AkzoNobel Shareholders Approve Final Dividend at Annual General Meeting
    PPG Maintains EcoVadis Gold Rating
    Sustainable Plastics Will Make Up More Than 15% of Production by 2030
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Getinge Receives FDA Clearance for Multiple Products
    Study Shows Benefits of CCHD Screening Using Masimo SET Pulse Oximetry
    TEAM Technologies Acquires ViruDefense
    Contract Pharma

    Latest Breaking News From Contract Pharma

    RDIF, Minapharm to Make Over 40M Doses of the Sputnik V Vaccine in Egypt
    Bora Pharmaceuticals Completes Health Canada Inspection
    Nanoform, Aprecia Partner to Advance 3DP Nanomedicines
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Johnson & Johnson Reports Sales Increase in First Quarter of 2021
    THG Launches Recycling Program in UK
    Knoll Printing & Packaging Commits to a Healthy Ocean and Planet
    Happi

    Latest Breaking News From Happi

    L’Oréal Successfully Defends Itself In Patent Infringement Lawsuit
    TFF Names 2021 Honorees for Lifetime Achievement Perfumer and Hall of Fame
    Ashland Donates $20,000 To Help Plant Trees
    Ink World

    Latest Breaking News From Ink World

    Kumon North America Adds Speedmaster XL 106 from Heidelberg
    Acrylic Resins Market Worth $21.9 Billion by 2025: MarketsandMarkets
    SE-DA Invests in Kornit Presto S
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Ashland commits to forest restoration
    Epson upgrades SurePress demo facility
    Xeikon helps converters navigate toner and inkjet
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Savaré Strengthens Technical Support for the Americas
    FiberVisions, Avgol Partner with Polymateria
    High-Tech Conversions Launches Wipes Dispenser
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    FDA Clears Orthofix's 3D-Printed FORZA Titanium TLIF Spacer System
    Patients Conclude Clinical Visits in Knee Osteoarthritis Treatment Study
    SeaSpine Begins Limited Rollout of WaveForm TO 3D-Printed Interbodies
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Identiv, Ameta International Announce US, Canadian Distribution Partnership
    Adesis Achieves ISO 9001:2015 Certification
    Louis Widmer SA Complies with EU Anti-Counterfeiting Directive with Zebra Technologies’ Solution

    Copyright © 2021 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