2012 FDA Warning Letters: What Can Be Learned?

November 22, 2012

So far in 2012, the FDA has issued nearly 300 warning letters. More than half of those were sent to companies within the pharmaceutical, medical device and dietary supplement industries

he report states that in the first year of Dr. Margaret Hamburg’s tenure as FDA Commissioner, the number of warning letters increased 42 percent. In her second year, the number of warning letters rose a staggering 156 percent.

Labeling & Misbranding

One major responsibility of FDA is to ensure that the products it is in charge of regulating are correctly labeled and branded. The agency spells out specific labeling guidelines on its website and provides detail to the requirements that businesses must meet in order to be in compliance.

When browsing the various warning letters issued by FDA, a broad spectrum of labeling and misbranding issues are identified. This includes, but is not limited to:

• Failure to bear adequate directions for use on labeling for the purposes for which the product is intended;

• Failure to furnish material or information required by FDA; and

• Failure to provide adequate directions for use on labeling.

Reviewing FDA guidance and regulations affecting the labeling and branding of products will help businesses ensure compliance and ultimately prevent enforcement action from occurring.

Current Good Manufacturing Practice Violations

FDA ensures the quality of drug products, medical devices and dietary supplements by carefully monitoring compliance with Current Good Manufacturing Practice (CGMP) regulations. These regulations contain minimum requirements for the methods, facilities, and controls used in the manufacturing, processing and packing of a regulated product. In short, CGMP rules in essence ensure the safety of a product.

Some of the most common reasons identified for receiving warning letters over CGMP violations include, but are not limited to:

• Failure to establish and maintain adequate procedures for implementing corrective and preventive actions;

• Failure to establish a quality policy and quality objectives; and

• Failure to adequately conduct quality audits.

In many cases, CGMPs are straightforward. But, if such regulations are not implemented in a firm’s Standard Operating Procedure (SOP), they can be easily overlooked. All businesses should regularly review such plans and update them to ensure they are consistent with regulatory expectations.

Misleading Promotional Claims

FDA wants to ensure that a complete picture of each product is adequately conveyed to the public by the companies it regulates and will likely review such marketing materials during an inspection. Product claims made on a company’s website are also up for review by the agency.

Three of the most common reasons identified for receiving warning letters over promotional materials include, but are not limited to:

• False and misleading claims;

• Unapproved use of drugs (i.e., “off-label” claims); and

• Intentions to be used to cure, mitigate, treat, or prevent of disease.

Source: http://www.pharmpro.com/Articles/2012/10/2012-FDA-Warning-Letters–What-Can-Be-Learned/

 


FDA: Compliance & Enforcement

September 21, 2010

Please find here  links to information about clinical investigators who have and/or are participating in clinical trials of pharmaceutical products as well as regulatory correspondence and restrictions resulting from noncompliance observed during bioresearch monitoring (BIMO) inspections.

Regulatory Activities

Clinical Investigator List

The Clinical Investigator Inspection List, maintained by the Center for Biologics and Evaluation Research, contains names, addresses, and other information gathered from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by CBER. These inspections were conducted as part of the Food and Drug Administration’s Bioresearch Monitoring Program. This list contains information on inspections that were closed after 1989.

Click here to check the details: Clinical Investigator List (PDF – 3.13 MB)

Bioresearch Monitoring Information System File (BMIS)

BMIS contains information submitted to FDA identifying clinical investigators (CIs), contract research organizations (CROs), and institutional review boards (IRBs) involved in the conduct of Investigational New Drug (IND) studies with human investigational drugs.

The information has been abstracted from FDA Forms 1571 and 1572 and other pertinent documents contained in IND submissions (e.g., C.V.s, cover letters, investigator lists, etc.). Please note that this file contains a separate entry for each time an investigator, CRO or IRB is identified in a new submission. For example, if an investigator is named in 10 INDs, his/her name will appear 10 times in this file.

Click here to check the details: Bioresearch Monitoring Information System File (BMIS)

Investigational Human Drugs Clinical Investigator Inspection List

The Clinical Inspection List, maintained by the Center for Drug Evaluation and Research, contains the names, addresses and other information obtained during FDA inspections of clinical investigators who have performed studies with human investigational drugs. The list contains information on investigators inspected since July 1977 whose files have been closed with a final classification.

Click here to check the details: Investigational Human Drugs Clinical Investigator Inspection List

Warning Letters

A Warning Letter is an informal advisory to a firm communicating the Agency’s position on a matter but does not commit FDA to taking enforcement action. The Agency’s policy is that a Warning Letter should be issued for violations which are of regulatory significance in that failure to adequately and promptly take corrections may be expected to result in enforcement action should the violation(s) continue.

Click here to check the details: Warning Letters

Source: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ComplianceEnforcement/default.htm


Medical Device Webinars / trainings @$149 (On-Demand)

July 23, 2009

Are you looking for online training for Medical Device Industries and Life Sciences?  What all it has –

  • 60 minutes of online training
  • Convenient access anytime, anywhere
  • A great way to meet your educational needs
  • Courses for the Life Sciences and Medical Device Industries

Check out here –

  1. Basic Requirements for Steam Sterilizer Validation per ISO 17665
  2. Best Practices for Managing FDA Investigators and Handling FDA 483 Observations
  3. Medical Device Complaints, MDR’s and Recalls
  4. Six Sigma Methodology for Process Validation
  5. Documenting a Risk-Based Quality System – for Compliance and Cost-Savings
  6. How to perform effective supplier audits, and avoid FDA 483’s and Warning letters
  7. Verification vs. Validation in Regulated Industries
  8. CAPA Essentials – core principles and practices needed to implement an effective and efficient CAPA process
  9. Introduction to Process Capability (Cp, CpK, Pp, Ppk)
  10. How to Use the System Risk Level to Save Time and Money on Computer System Validations
  11. Implementing the new International and FDA accepted Software Development Standard IEC 62304
  12. Risk Management Activities during Design Input
  13. Developing a Robust CAPA System
  14. Complying with 21CFR Part 11-Understanding the Role of Predicate Rules
  15. The New Dietary Supplement Good Manufacturing Practices
  16. Configuration Management and Change Control for Computer Systems
  17. Cleanroom Operation, Maintenance and Operators
  18. Conducting and Documenting Proper Risk Analysis In compliance with ISO 14971
  19. 510(k) Preparation for a Small to Medium-Sized Company
  20. Applying Lean Documents to a Project – how to create a project file, follow design controls, yet maintain a lean set of project documents.