• 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

    Formulating with Alternatives In Personal Care Products
    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
    PCPC Virtual Summit Features Legal & Regulatory Conference

    Biolage Unveils ColorBalm Hair Conditioners With Hair Color Benefits

    HCPA Opens Registration for New Horizons Cleaning Industry Conference

    Cosmoprof Worldwide Bologna Is Postponed Again

    Amyris Buys Another Beauty Brand
    Blog
    Online Exclusives
    Infographics
    Podcasts
    Whitepapers
    Videos
    Expert's Opinion
    HappiTV
    eBook
    Surveys
    International Top 30 Report
    Top 50 Report
    Top Companies
    30. Mandom

    26. Menard

    21. Boticario Group

    4. SC Johnson

    37. High Ridge Brands
    Actives
    Functional Ingredients
    Pigments
    Polymers
    Preservatives
    Surfactants

    Reckitt Seeks Germ-Killing Innovations

    Videobite: Innospec's Answer to the 1,4-Dioxane Problem

    BASF Increases Price of Kaolin

    Kao Launches Online Beauty Store in Europe

    Carlyle To Acquire Majority Stake in Beautycounter
    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

    Reckitt Seeks Germ-Killing Innovations

    PCPC Virtual Summit Features Legal & Regulatory Conference

    Biolage Unveils ColorBalm Hair Conditioners With Hair Color Benefits

    Cosmoprof Worldwide Bologna Is Postponed Again

    Amyris Buys Another Beauty Brand
    Lab Equipment
    Mixing
    Packaging
    Testing

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

    Tesco Eliminates Plastic Bags from Online Orders

    Hourglass To Launch Sustainable Cosmetics Line

    Carbon Data for Personal Care Labels

    L’Oréal Hong Kong Launches Cross-Brand Recycling Program
    Contract Manufacturing / Private Label Directory
    Buyer's Guide
    Add New Company
    Corporate Profiles
    International Buyers Guide Companies
    BotanicalsPlus

    Lubrizol Life Science

    Vantage Specialty Ingredients

    Croda

    Baralan USA
    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

    Warning Letter for OTC Acne & Sunscreen Manufacturer

    FDA finds violations at Goshen, NY-based facility.

    Warning Letter for OTC Acne & Sunscreen Manufacturer
    Related CONTENT
    • Warning Letter Sent to SC Johnson Professional
    • TriPollar Stop Prepares for Sales in US
    • FDA Warns CBD Lotion Seller
    • The Ongoing Challenges of Category I UV Filters and FDA
    • High Interest in CBD
    Happi staff10.16.19
    The US Food and Drug Administration has issued a warning letter to The Skin Atelier, Inc., d.b.a. Skinprint, Goshen, NY, following an inspection conducted from March 28 to April 4, 2019. The agency said it found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, including acne treatments and sunscreens including: Spot-On with 5% Micro-Benz Benzoyl Peroixde  Spot Treatment, Reflect SPF 50 Broad Spectrum Sunscreen and Blemish Control Cleanser 2% Salicylic Acid. 

    According to FDA, Spot-On with 5% Micro-Benz Benzoyl Peroixde Spot Treatment is an unapproved new drug in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Introduction or delivery for introduction of such product into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d). FDA also noted that Reflect SPF 50 Broad Spectrum Sunscreen”and Blemish Control Cleanser 2% Salicylic Acid are misbranded drugs under section 502(c) of the FD&C Act, 21 U.S.C. 352(c). 

    According to FDA, the firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).

    The agency noted that The Skin Atelier's finished drug product release testing was inadequate for multiple over-the-counter (OTC) topical drug products, including but not limited to Ultra Sheer SPF20, Reflect SPF50, and Blemish control cleaner. It said the firm lacked identity and strength testing for each active ingredient as part of the finished drug product release testing;  lacked validation or verification to determine adequacy of the microbial test kit and methods used for microbiological release testing of finished drug products; and lacked testing for objectionable microorganisms.

    FDA also alledges that The Skin Atelier's quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).

    FDA said the The Skin Atelier's QU failed to ensure adequate procedures and did not provide adequate oversight of manufacturing activities. For example, the firm lacked many important quality and production procedures, including appropriate provisions for batch review/disposition, deviations, out-of-specification results, investigations, complaints, recalls, change controls, annual product reviews, equipment qualification, method validation/verification, and controls for issuance, handling, reconciliation, and storage of OTC drug product labeling.

    FDA said the company’s review of batch records was inadequate and that its supplier qualification was inadequate. According to FDA, the company accepted incoming components, such as titanium dioxide, zinc oxide, and salicylic acid, from suppliers solely based on certificates of analysis. The firm’s QU failed to ensure the suitability of all incoming lots of components for use in drug product manufacturing.

    This violation is a repeat violation fromThe Skin Atelier’s last inspection in 2006, said FDA. 

    FDA also said the company 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)).

    The FDA said Skinprint also failed to establish and follow adequate written procedures for cleaning and maintenance of equipment. 

    The full letter can be accessed here.
     
    Related Searches
    • it
    • products
    • suppliers
    • testing
    Related Knowledge Center
    • Sun Care
    • Skin Care
    • OTC/Medicated
    Suggested For You
    Warning Letter Sent to SC Johnson Professional Warning Letter Sent to SC Johnson Professional
    TriPollar Stop Prepares for Sales in US TriPollar Stop Prepares for Sales in US
    FDA Warns CBD Lotion Seller FDA Warns CBD Lotion Seller
    The Ongoing Challenges of Category I UV Filters and FDA The Ongoing Challenges of Category I UV Filters and FDA
    High Interest in CBD High Interest in CBD
    Chinese Wipes Maker Flagged by FDA Chinese Wipes Maker Flagged by FDA
    FDA Sends Warning Letter To Sunscreen Manufacturing Site FDA Sends Warning Letter To Sunscreen Manufacturing Site
    FDA Issues Final Rule on Hand Sanitizers FDA Issues Final Rule on Hand Sanitizers
    New FDA Warning Letters New FDA Warning Letters
    FDA Expands Asbestos Recall FDA Expands Asbestos Recall
    FDA on CBD FDA on CBD
    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
    FDA Issues Final Guidance on MUsT for OTC Monograph FDA Issues Final Guidance on MUsT for OTC Monograph
    FDA Hosting Public Meeting To Prep for ICCR-13 FDA Hosting Public Meeting To Prep for ICCR-13

    Related Breaking News

    • Actives | Functional Ingredients | Hair Care | Skin Care

      New Synthetic Biology Coalition Formed in US

      Genomatica backs new formation to promote investment and support for the industry.
      Christine Esposito, Managing Editor 04.15.21

    • Functional Ingredients | Hair Care | Skin Care
      BASF Increases Price of Kaolin

      BASF Increases Price of Kaolin

      Higher prices for skin and hair care ingredient blamed on cost pressures in manufacturing, labor and logistics.
      Tom Branna, Editorial Director 04.14.21

    • Actives | Functional Ingredients | Skin Care
      Kao Launches Online Beauty Store in Europe

      Kao Launches Online Beauty Store in Europe

      Sensai-cosmetics.com provides personalized beauty services tailored to individual needs.
      Tom Branna, Editorial Director 04.14.21


    • Skin Care
      Neutrogena Takes Action on Skin Health Disparities

      Neutrogena Takes Action on Skin Health Disparities

      “For People With Skin” is a multi-faceted plan to address inequities including access and dermatologist training with skin of color.
      Christine Esposito, Managing Editor 04.14.21

    • Actives | Color Cosmetics | Functional Ingredients | Personal Cleansers | Skin Care
      Carlyle To Acquire Majority Stake in Beautycounter

      Carlyle To Acquire Majority Stake in Beautycounter

      The $1 billion acquisition fast-tracks growth in the clean beauty space.
      Tom Branna, Editorial Director 04.13.21

    • 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


    • Skin Care | Sun Care
      Supplement Said To Deliver Anti-Aging and Sun Protection Benefits

      Supplement Said To Deliver Anti-Aging and Sun Protection Benefits

      Inner Glow was developed by dermatologist Dr. Noreen Galaria and a plastic surgeon.
      Christine Esposito, Managing Editor 04.13.21

    • Skin Care
      Mini Bloom is New Clean Skin Care for Babies

      Mini Bloom is New Clean Skin Care for Babies

      Range created by co-founder of Goldfaden MD skin care.
      Christine Esposito, Managing Editor 04.13.21

    • Skin Care
      Elemis London Arrives at Bloomingdale’s

      Elemis London Arrives at Bloomingdale’s

      Offers a wide selection of clean beauty products for a variety of skincare needs.
      Charles Sternberg, Assistant Editor 04.12.21


    • Skin Care
      Courtin-Clarins Family Invests in Pai Skincare

      Courtin-Clarins Family Invests in Pai Skincare

      Makes a $9 million investment in direct-to-consumer brand.
      Tom Branna, Editorial Director 04.12.21

    • Color Cosmetics | Fine Fragrance | Skin Care
      Estée Lauder EVP-Communications To Retire

      Estée Lauder EVP-Communications To Retire

      Alexandra Trower will leave July 1, 2021.
      Tom Branna, Editorial Director 04.12.21

    • Color Cosmetics | Skin Care
      Nature’s Beauty Debuts Vegan Natural Body Care at Walgreens

      Nature’s Beauty Debuts Vegan Natural Body Care at Walgreens

      Wellness-based personal care collections focus on sleep, detox and stress relief with aromatherapy.
      Melissa Meisel, Associate Editor 04.12.21


    • Color Cosmetics | Household Cleaning | Laundry Care | Personal Cleansers | Skin Care | Sun Care
      The Honest Company Files for IPO

      The Honest Company Files for IPO

      Household and personal products maker said sales jumped over 27% last year.
      Tom Branna, Editorial Director 04.11.21

    • Actives | Color Cosmetics | Fine Fragrance | Hair Care | Pigments | Skin Care | Surfactants
      Guangzhou Builds Beauty Park To Woo L

      Guangzhou Builds Beauty Park To Woo L'Oréal, Estée Lauder

      Part of China's plan to encourage business development in the region.
      Tom Branna, Editorial Director 04.11.21

    • Actives | Color Cosmetics | Functional Ingredients | Household Cleaning | Skin Care
      What You’re Reading on Happi.com

      What You’re Reading on Happi.com

      The most-viewed news on our site for the week ended April 10, 2021.
      Tom Branna, Editorial Director 04.11.21

    Trending
    • Sunscreen On The Spot
    • Henkel Appoints New EVP Of Beauty Care
    • BASF Increases Price Of Kaolin
    • Neutrogena Takes Action On Skin Health Disparities
    • Top Trending Skin Care Products Of 2021
    Breaking News
    • PCPC Virtual Summit Features Legal & Regulatory Conference
    • Biolage Unveils ColorBalm Hair Conditioners With Hair Color Benefits
    • New Synthetic Biology Coalition Formed in US
    • HCPA Opens Registration for New Horizons Cleaning Industry Conference
    • Cosmoprof Worldwide Bologna Is Postponed Again
    View Breaking News >
    CURRENT ISSUE

    Household & Personal Care Wipes Spring 2021

    • 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
    • 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

    Study on Kemin’s DailyZz Botanical Supplement Yields Sleep Quality, Next-Day Performance Benefits
    FDA’s Dr. Cara Welch Opening Speaker at the 9th AHPA Botanical Congress
    Arla Foods Enters New Partnership to Reduce Malnutrition With Dried Papaya Snack
    Coatings World

    Latest Breaking News From Coatings World

    Jebsen & Jessen, Innospec Sign Distribution Agreement
    Axalta Schedules 1Q 2021 Earnings Conference Call
    SONGWON, Chemo International Inc. Announce Distribution Partnership
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    FDA Grants De Novo Clearance to Medtronic’s GI Genius Model
    Acutus Medical Receives FDA Clearance of AcQCross
    Thermo Fisher Scientific to Acquire PPD for $17.4 Billion
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Obituary Notice: Russell “Russ” Haines
    Abenza Chooses North Carolina for New Biologics Manufacturing Site
    Catalent Adds Cryogenic Capabilities at Philadelphia Facility
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Lush Launches Recycling Scheme in UK and Ireland
    Loud Lacquer Partners with Hush Puppies
    Tula Teams Up with 5 Influencers To Launch Skin Kits
    Happi

    Latest Breaking News From Happi

    PCPC Virtual Summit Features Legal & Regulatory Conference
    Biolage Unveils ColorBalm Hair Conditioners With Hair Color Benefits
    New Synthetic Biology Coalition Formed in US
    Ink World

    Latest Breaking News From Ink World

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

    Latest Breaking News From Label & Narrow Web

    FINAT to hold online networking, educational forum
    Epson SurePress reaches milestone
    Maxcess updates user interface for Fife guiding Sensor
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    First Quality to Discontinue Tampon Operations
    Freedonia Tracks Demand for Personal Hygiene Nonwovens
    TMC Supplies Sevinçler with D-Namic Stacker and Bagger
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Mainstay Medical Launches ReActiv8 in Australia
    Biogennix Rolls Out Agilon Strip Bone Graft
    Global Bone Tumor Ablation Devices Market to Top $111 Million by 2027
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Virtual ASMC 2021 Spotlights Advanced Semiconductor Manufacturing Excellence
    LG Display Cuts Down CO2-eq Emissions by 3 Million Tons in 2020
    European Commission's Innovation Radar Acknowledges 3 ARMOR Innovations

    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