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.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Chronic Lack of Quality Testing Leads to FDA Alert for Compounder

Chronic Lack of Quality Testing Leads to FDA Alert for Compounder

August 1, 2014

The FDA asked healthcare professionals to watch out for drugs compounded by a Dallas-based pharmacy after a recent inspection revealed 22 lots of sterile drugs failed quality tests.

The agency issued a July 19 safety alert on drugs compounded by Downing Labs and its subsidiary Nuvision Pharmacy following a June to July inspection of the compounder’s facility that found the lots failed sterility or endotoxin tests from April 2013 to June 23, 2014. “In each case, the investigations were either absent or incomplete,” says a Form 483 issued July 16.

Downing’s contract laboratory determined that a lot of folic acid 10 mg and two lots of cyanocobalamin 1 mg/ml failed sterility and were contaminated by bacteria. However, no investigation was performed as to how the lot failed sterility, says the 483 with 15 observations.

All of the lots were destroyed except for two, with a lot of cyanocobalamin awaiting distribution after being re-tested for sterility and endotoxins. A lot of folic acid is being held in quarantine pending destruction, the FDA says.

The investigator also found that Downing didn’t do endotoxin testing on approximately 180 lots from April 2013 to June 2014.

Downing’s subsidiary Nuvision has tangled with the FDA before, rejecting a request from the agency last summer to recall questionably sterile products. The pharmacy noted at the time that it follows U.S. Pharmacopeia standards for compounders.

Downing did not return a request for comment as of press time.

Drug GMP training never ends, and rightly so. But there’s no point in reinventing the training wheel — not when a top-quality option is available. Train your staff the easy way with Drug GMP Training Course: A 17-Module Customizable Training Series.

Pharmaceuticals GMPs

Upcoming Events

  • 28Jun

    Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

  • 13Jul

    FDA Ad and Promo Enforcement Trends: Past, Present and Future

  • 28Jul

    EU-MDR’s Growing Pains: Are You Current with the Latest Developments?

  • 28Jul

    Is Your Product a Drug or Device — and Does It Matter?: A Recent Appeals Court Decision Says It Does

  • 02Aug

    Medical Device Cybersecurity: Understand the Latest Developments

  • 03Aug

    Pharmaceutical Process Validation: Best Practices for Success

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • Okami Medical’s LOBO-7 and LOBO-9 Vascular Occluders Cleared

  • FDA Puts Clinical Hold on Astellas Late-Onset Pompe Disease Clinical Trial

  • FDA Provides Update on GE Healthcare’s Recall of Its Carescape R860 Ventilators

  • Gilead Resubmits NDA for Lenacapavir Following Complete Response Letter

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 – Toll free 888.838.5578

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing