We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Utah OTC Maker Warned for Shoddy Quality Unit, Lack of API Testing

Utah OTC Maker Warned for Shoddy Quality Unit, Lack of API Testing

WarningTape.gif
August 1, 2019

A West Jordan, Utah company that manufactures over-the-counter drug products has been hit with a warning letter for multiple issues at its facility, including a lack of API testing and a failure to put quality unit procedures in place.

SnugZ USA was inspected from Nov. 26-30, 2018 and knocked for releasing numerous OTC drug products without properly testing the identity and strength of their active ingredients. The products, which include the company’s Naawk Aloe Relief Gel + Lidocaine, were also not checked for critical microbial attributes, such as the presence of objectionable microorganisms.

“Without testing each batch, you do not have scientific evidence that all drug product batches conformed to specifications before release,” the agency said.

View today's stories

Pharmaceuticals Inspections and Audits

Upcoming Events

  • 21Apr

    CDER’s Most Significant Guidance Priorities for 2021: Biosimilars/Biologics, Generics/Exclusivity, Real-World Evidence, Drug Development and Digital Health

  • 26Apr

    MAGI's Clinical Research vConference — Spring 2021

  • 06May

    The World of Post-COVID-19 Clinical Trials: How to Prepare for What’s Coming Next

  • 12May

    Extractables and Leachables: 101

  • 25May

    How Can the Accelerated Availability of Pfizer-BioNTech’s COVID-19 Vaccine be Replicated?

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • EMA logo European Medicines Agency logo

    EMA Reviews GSK’s and Vir’s VIR-7831 for COVID-19

  • CE mark

    Hensler Surgical Technologies Earns CE Mark for Bone-Fusion Device

  • Eli lilly logo

    Eli Lilly Asks FDA to Nix EUA for Bamlanivimab Alone

  • CE mark

    Alimetry Earns CE Mark for Wearable Gastric Disease Diagnostic

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing