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 News
    • Trending
    • Commercial Operations
    • GMPs, Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Drug Daily Bulletin
    • Drug Industry Daily
  • Device News
    • Trending
    • Commercial Operations
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Device Daily Bulletin
    • FDAnews Device Daily Bulletin Premium
  • Books
    • FDAnews Books Library
    • Drug Books
    • Device Books
  • Training/Events
    • Webinar Training Pass
    • Events
  • Resources
    • Form 483s Database
    • FDA Approved Drugs
    • eCFR and Guidances
    • White Papers
  • CenterWatch
  • About Us
    • The Company
    • Contact Us
  • Advertising
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Form 483 » Gramercy Extremity Orthopedics

Gramercy Extremity Orthopedics - Oct. 6, 2022

Issue Date

Oct 06, 2022

Region

Southwest

Category

Device
$117.00

Contact Name

Michael P. Simpson

Contact Title

President & CEO

Address 1

1239 N. Glenville Dr.

City

Richardson

State

TX

Zip/Postal Code

75081-2412

Inspection Range

Oct 03, 2022 - Oct 06, 2022

Pages

4

First Observation

Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.

Investigator(s): Roy Baby and Katlin N. Stubbs
Buy One Year Unlimited Access for $1,297.00
Log In & Download

Search By Date Issued

Search By Category

Drug
Device
Clinical

Search By Company/

Clinical Investigator

Search By Region

Search By FDA Investigator

Search By Keyword

  • 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 or Share My Data
Footer Logo

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

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing