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 » California Contract Manufacturer Warned Over CGMP Violations

California Contract Manufacturer Warned Over CGMP Violations

December 3, 2018

Los Angeles, California OTC drugmaker Product Packaging West drew a warning letter from the FDA for current good manufacturing practice violations observed at its facility, including inadequate recordkeeping and component testing.

The agency inspection, conducted from March 7 to 13, brought to light multiple problems at the facility. For example, the firm failed to test incoming components for identity, purity, quality and strength, and failed to check the reliability of its suppliers’ certificates of analysis.

The facility “failed to perform identification testing for all incoming glycerin lots to verify identity and determine whether diethylene glycol or ethylene glycol was present,” the agency said. Because of this, the firm could not ensure the component lots were acceptable for use in drug manufacturing.

View today's stories

Pharmaceuticals Inspections and Audits

Upcoming Events

  • 13Jul

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

  • 27Jul

    Applying the Lessons of the Pandemic to Your Upcoming Trial

  • 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

  • FDA Warns Baby Neck Floats Used in Water Therapy Can Cause Death or Injury

  • U.S. Government Inks $3.2 Billion Contract With Pfizer-BioNTech for Vaccine Booster Campaign

  • FX Receives FDA Clearance for Its FX V135 Shoulder Arthroplasty Platform

  • FDA Recommends Modified COVID-19 Vaccine Boosters Adapted to Omicron BA.4 and BA.5 Subvariants

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