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 » North Carolina API Manufacturer Cited for Serious GMP Failures

North Carolina API Manufacturer Cited for Serious GMP Failures

July 29, 2019

The FDA hit API and repackaging facility Giles Chemical  of Waynesville, N.C., with a lengthy Form 483 for multiple violations including the use of “reclaimed water” in manufacturing API products.

In a repeated observation from a previous inspection, the FDA investigator witnessed production workers shoveling piles of magnesium sulfate API slurry from the floor into bins used for nonconforming API material.

The slurry was contaminated with “reclaimed water” — water  taken from the floor and recycled from drains — that was not tested to prove its suitability for manufacturing APIs. The slurry wasn’t assessed by the quality unit or approved for reuse before processing.

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