fda inspectional and regulatory enforcement trends: key focus on trends in

Anticipating FDA Warning Letters?

Upload: compliance1

Post on 30-Dec-2015

30 views

Category:

Documents

0 download

Report

Download

Embed Size (px):

DESCRIPTION

Understand current Food and Drug Administration (FDA) regulatory guidance as well as current regulatory trends with regards to consent decree.\n - PowerPoint PPT Presentation

TRANSCRIPT

Page 1: FDA Inspectional and Regulatory Enforcement Trends: Key Focus on Trends in

Anticipating FDA Warning Letters?

Page 2: FDA Inspectional and Regulatory Enforcement Trends: Key Focus on Trends in

WHAT IS A WARNING LETTER?

A Warning Letter is issued by the FDA to a

regulated manufacturer if it is found that any significant regulatory

violations have occurred.

Page 3: FDA Inspectional and Regulatory Enforcement Trends: Key Focus on Trends in

Nonconformance with Good Manufacturing Practices (GMP)

False Claims About a Product

Inadequate Training for Personnel

Wrong directions for Use and so on…

Violations Identified in Warning Letters Include-

Page 4: FDA Inspectional and Regulatory Enforcement Trends: Key Focus on Trends in

FDA Has Been Busy! (2000-2015)

300000+ Inspections

170000+ Facilities

130000+ 483S

4500+ Inspectors

Page 5: FDA Inspectional and Regulatory Enforcement Trends: Key Focus on Trends in

Page 6: FDA Inspectional and Regulatory Enforcement Trends: Key Focus on Trends in

What Are The Trends?

Page 7: FDA Inspectional and Regulatory Enforcement Trends: Key Focus on Trends in

Wat

ch O

ut f

War

nin

g L

ette

r Si

gns • Long standing internal problems that

have not yet caught the attention of the FDA but are known within the company

• Form 483 notifications (the most obvious predictor of Warning Letters)

• Red flags from the Quality Unit • Adverse events • High volume of customer complaints • Prior investigations about the same

issue or same type of issue • FDA responses to communications

from the company that do not signal satisfaction with issue resolution and so on

• Product contamination • Off-Label Promotional activities that

have caught the attention of the FDA • DDMAC letters • Repeated FDA inspections of facilities

Page 8: FDA Inspectional and Regulatory Enforcement Trends: Key Focus on Trends in

For more on FDA Compliance

Visit our Website

www.complianceonline

FDA Compliance

Thankyou !

http://www.complianceonline.com/fda-regulatory-compliance-training-30001-c

http://www.complianceonline.com/i-9-form-immigration-compliance-is-your-company-ready-for-ice-webinar-training-703930-prdw

Food & Beverage Industry Brochure - daemar.com · applications including: FDA Silcone, FDA EPDM, FDA NBR, FDA Neoprene, FDA FKM (Viton), FDA PTFE, FDA PTFE Encapsulated, FFKM (Kalrez)

FDA Social Media Regulation and Enforcement: Emerging ... · FDA Social Media Regulation and Enforcement: Emerging Trends and Guidelines for Pharmaceutical Manufacturers. Agenda

CAPA Inspectional Guidelines & Flow Chart - Quality Digest Inspectional Guidelines... · Corrective and Preventive Actions (CAPA) Inspectional Objectives 1. Verify that CAPA system

Pharmacy Trends in Workers’ Compensation · • July 2015 - FDA approved Praluent ... disorientation, impacts abstract thinking • Psychomotor effects- impaired driving and performance

Key Trends In Quality and GMP Inspections · Key Trends In Quality and GMP Inspections ... if there are CGMP gaps, are they chronic or ... April 1991 -A highly respected FDA Investigator

BPV 031 BPV Request for Extension of Inspectional

Summary of Inspectional Findings Food Allergen Partnership 1999 - 2000 Theresa C. Dziuk Minneapolis District FDA August 13, 2001

FDA Form 483 (Inspectional Observations) - Top Violations 2013

FDA 483 Observations and Warning Letter Trends€¦ · Overall Trends in FDA 483s from 2016-2018 •Enforcement activity has been relativity consistent in the past 3 years, with a

FDA Updates and Recent Trends in the Inspection of Sterile ... · FDA Updates and Recent Trends in the Inspection of Sterile Dosage Form. Alonza E. Cruse. Director, Office of Pharmaceutical

205750Orig1s000 - Food and Drug Administration...Feb 11, 2014 · Calbon . FDA . Drolban . FDA . Cholan-HBM . FDA . Cholesterol . External . Cholbam *** FDA . Clobazam . External,

FDA Oral History Interviews, FDA retired scientists

THE EMERGENCY GUIDE TO FDA WARNING LETTERS & FDA 483 · 2018-12-13 · The Emergenc Gide to FDA Warning Letters & FDA 483 The FDAGrop.com 4 FDA 483 RESOLVING FDA 483 OBSERVATIONS

POSTMARKETING ADVERSE DRUG EXPERIENCE INSPECTIONAL PROGRAM CDR Thomas R. Berry, RPh FDA, Investigator RAL-RP / ATL-DO

Globalization and FDA Compliance Trends...Globalization and FDA Compliance Trends Letitia Robinson, PhD, RN/CAPT, USPHS Country Director, India Office Office of International Programs,

FDA - CAT002.E3 _ FDA 800_900

CGMP Trends, Data Integrity and Handling an FDA Inspection€¦ · FDA Draft Guidance, “Data Integrity and Compliance with CGMP” (April 2016) 8 ... o internal reports and memos

READING LESSON 13: INSPECTIONAL READING · 2021. 4. 6. · Reading Lesson 13: Inspectional Reading 71 13 READING LESSON 13: INSPECTIONAL READING From How to Read a Book, pages 32-35:

Aurobindo Unit VI - U S Food and Drug … M. Barbosa INSPECTIONAL OBSERVATIONS REVERSE OF THIS PAGE FORM FDA 483 (9/08) PREVIOUS EDITION OBSOLETE Title Aurobindo Unit VI Author FDA/CDER

Torrent Pharmaceuticals Limited Indrad Gujarat India 4 … DOCUMENT LISTS OBSERVATIONS MADE BY THE FDA REPRESENTATIVE(S) DURING THE INSPECTION OF FACILITY. THEY ARE INSPECTIONAL OBSERVATIONS;

Pharmaceutical Compliance Current Trends · Pharmaceutical Compliance Current Trends: ... “According to the most recent report, ... [FDA Form] 1572 and if they do something disgraceful

FAD DIETS and the FDA Finding Factual Information About Todays Top Health Trends Spencer S. Eccles Health Sciences Library

FDA Alliance for a Stronger FDA

Case for Quality: FDA & Industry 2014 Update for Quality: FDA & Industry 2014 Update ... Total # Inspectional ... Case for Quality: Maturity Model October 6 - 8,

Current Major Laboratory Initiatives - APHL · Puerto Rico have contracts in place with FDA totaling approximately $11.9 million. Objective: 1. Place major inspectional emphasis on

FDA 483 Warning Letter –Trend Analysisbioclinlabs.com/wp-content/uploads/2016/05/Warning-letter-trends... · FDA 483 Warning Letter –Trend Analysis Garry Wright European Laboratory

Webinar on Tobacco Industry Trends for Computer Systems ... · The Tobacco Control Act went into effect by the FDA on June 22, 2009. Through this ruling, the FDA regulated cigarettes,

THE EMERGENCY GUIDE TO FDA WARNING …€¦ · The Emergenc Gide to FDA Warning Letters & FDA 483 The FDA Grop.com 1 THE EMERGENCY GUIDE TO FDA WARNING LETTERS & FDA 483 …

Health Information National Trends Survey 4 (HINTS 4) … Information National Trends Survey 4 ... and the specific goals of FDA, the regular sampling strategy of HINTS was altered

FDA Enforcement Inspections,Trends Q&A session with a Recent FDA Investigator

American Society for Quality Richmond, VA Section March 8 ... · Inspectional Findings and Trends ... – Raw data (sample preparation) not maintained – Discarded data in the trash

US FDA Update: Recent Trends in the Regulation of ...€¦ · Darzalex (daratumumab), Tecentriq (atezolizumab), Lartruvo (olaratumab), Bavencio (avelumab) 20 Expedited Development-

FDA Presentation FDA Presentation

€¦ · FORM FDA 483 EMPLOYEE(S) SIGNATURE Tamil Arasu, Investigator Darren S. Brown, Investigator PREVIOUS EDITION OBSOLETE INSPECTIONAL OBSERVATIONS . ADDRESS AND PHONE

FDA Perspective: Recent Trends in the Regulation of ... Perspective: Recent Trends in the Regulation of Biopharmaceuticals Sarah Kennett, Ph.D. Division of Monoclonal Antibodies Office