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FDA cGMP Violations

Is Your Pharmaceutical Company Violating FDA Good Manufacturing Practices?

We Help Pharmaceutical Whistleblowers Report cGMP Violations and Maximize Cash Awards

With today’s immense market for prescription drugs, pressure to meet demand has many drug manufacturers ignoring FDA current good manufacturing practices (cGMP) requirements and overall quality control. Pharmaceutical plants, including overseas facilities, continue to fall short of FDA regulations, producing adulterated, substandard, contaminated or ineffective drug components.

Because of limited FDA resources, and the serious threat to health care costs and public safety, the Department of Justice, FDA and Department of Health and Human Services are seeking out pharmaceutical company insiders to help uncover and report FDA drug manufacturing violations.

The need for whistleblowers is especially great for contract manufacturing companies and offshore generic producers. In many countries, it could take years before the FDA can schedule an audit.

If you know of a drug company, contract manufacturing facility, API maker, pharmaceutical manufacturer, compounding pharmacy or distributor that is misrepresenting product ingredients, violating FDA current good manufacturing practices, mislabeling drugs, or placing adulterated products into the market, you may be eligible to file a pharmaceutical whistleblower lawsuit and collect a large cash award.

Obtaining a large cash whistleblower reward against big pharma requires aggressive legal advocates and superior investigative resources. Anyone can call the FDA emergency reporting hotline but doing that does not get you a reward. Obtaining an award means filing a pharmaceutical whistleblower lawsuit in federal court. With the right lawyers and experts, it is not difficult and requires no money out of your pocket.

At the Pharmaceutical Integrity Coalition, we applaud pharmaceutical professionals who are willing to help put a stop to dangerous drug manufacturing practices. Our mission is to supply pharmaceutical whistleblowers with every legal tool necessary to ensure a winning False Claims Act (FCA) lawsuit.*

Those who report pharmaceutical fraud through the Pharmaceutical Integrity Coalition receive:

  • Aggressive, nationally recognized legal representation
  • Specialized team of FDA qualified investigators
  • Full case preparation optimized for maximum cash award
  • Complete protection of your pharmaceutical whistleblower rights
  • Security, privacy and confidentiality

We do not charge whistleblowers anything for our services.

The Pharmaceutical Integrity Coalition represents U.S. and international medical device and drug manufacturing company executives, pharmaceutical calibration specialists, pharmaceutical sales representatives, public health administrators, quality control specialists and others with knowledge of pharmaceutical FDA violations.

We work to ensure your claim is successful, the offender is held accountable, your cash award is maximized, and your rights and privacy are protected. Contact the Pharmaceutical Integrity Coalition toll free worldwide at +1 202.780.9957 or report anonymously at [hidden email]. (Please do not use a work computer or device or a work email address to contact us.)

What Types of FDA cGMP Violations Are False Claims Act Liable?

Companies that violate FDA good manufacturing practices may be in violation of federal and state False Claims Acts when the resulting substandard or adulterated products are paid for by government-funded programs (Medicare, Medicaid, TRICARE).

Government program billings for adulterated drugs (drugs produced in violation of FDA cGMP requirements) are considered “false claims.” Pharmaceutical companies or medical device manufacturers who sell adulterated products, or who receive from government programs to produce substandard products may violate the False Claims Act.

Common examples of FDA cGMP violations that may be False Claims Act liable include:

  • Adding, omitting or altering raw data in control records
  • Allowing significant deviations in drug component manufacture and bulk drug substance
  • Allowing untrained, unqualified personnel to aid in drug manufacture, processing, packing or holding.
  • Analytical errors (using an average of sample results that include out of spec data)
  • Destroying batch records prior to required date
  • Failure to demonstrate consistent, reproducible product performance between batches
  • Failure to establish proper controls to ensure product strength, purity and quality
  • Failure to examine batches / products related to other spec failures
  • Failure to investigate out of spec batches
  • Failure to investigate recurring contamination
  • Failure to maintain manufacturing equipment
  • Failure to maintain valid computer systems
  • Failure to prevent contamination
  • Failure to reject out of spec test batches
  • Failure to review drug production records before release
  • Failure to take corrective action and ensure no repeated incidents
  • Failure to validate manufacturing processes and equipment
  • Improper API testing
  • Improper Quality Control protocols
  • Poor sanitization, sterilization and cleaning practices
  • Preparing, packing or holding products in unsanitary environments
  • Substandard management of electronic data
  • Using lots without prior testing and quality control approval
  • Using outdated, non-CGMP compliant or inaccessible SOPs

Remember, a drug doesn’t have to be less effective or impure to violate the False Claims Act. It only has to have been produced under conditions that violate FDA cGMP regulations (adulterated).

The Pharmaceutical Integrity Coalition has quietly worked behind the scenes in many prescription drug False Claims Act whistleblower cases. We carefully prepare FCA claims to maximize cash awards for U.S. and international pharmaceutical professionals with inside knowledge of FDA cGMP violations. And we are always a second voice or ear should you need us. Because we understand your world, we can help bridge the gap between pharmaceutical cGMP and the legal system (lawyers, prosecutors and courts).

To report drug manufacturing violations, contact the Pharmaceutical Integrity Coalition toll free worldwide at +1 202.780.9957 or report anonymously at [hidden email]. We maintain strict confidentiality and will not share your information with others.

Pharmaceutical False Claims Act Awards and Whistleblower Protection (Subtitle)

Under the False Claims Act [31 U.S.C. §3729], drug manufacturers whose cGMP violations cause government programs to receive false claims must pay a $11,000 to $21,000 fine per false claim, plus treble damages.

Government recoveries for pharmaceutical whistleblower lawsuits therefore often range in the ten-million to hundred-million-dollars.

You do not have to be a citizen or resident of the United States in order to file a whistleblower lawsuit or receive a cash reward. In fact, some of the best whistleblowers are foreign nationals. With 80 to 85% of America’s prescription drugs being imported today, many of the people with the best inside knowledge are located in China, India and Mexico.

Because pharmaceutical whistleblowers collect between 15% and 30% of the total government recovery, cash whistleblower awards are significant. False Claims Act whistleblowers collected $635 million in 2017 alone.

In addition, federal and state False Claims Acts provide pharmaceutical whistleblowers with the ability to sue for damages should they experience employer retaliation (job termination, demotion, threats, harassment, promotion denial, suspension) in response to their efforts to stop an FCA violation. [31 U.S.C. § 3730(h)]

If you have knowledge of a medical device manufacturer, drug manufacturer, compounding facility, pharmaceutical company or other entity that is violating FDA good manufacturing practices, we are here to protect your rights and privacy. Contact the Pharmaceutical Integrity Coalition toll free worldwide at +1 202.780.9957 or report anonymously at [hidden email].

First to File and Statute of Limitations Apply

Act fast! Under the False Claims Act, only the first to report a potential FCA violation is eligible for a pharmaceutical whistleblower award. In addition, time limits may apply to your case.

If you suspect a pharmaceutical company of violating cGMP regulations or distributing adulterated drugs, don’t hesitate to take action. Your report makes a difference. Contact the Pharmaceutical Integrity Coalition toll free worldwide at +1 202.780.9957 or report anonymously at [hidden email].

*If you have no interest in obtaining a reward, we can also help insure your hotline call is properly formatted and investigated. We believe, however, that the only way to stop poor manufacturing practices is through a False Claims Act complaint. Once a formal complaint is filed, that case goes to the top of the investigations list. The FDA’s hotline receives thousands of calls. Unfortunately, most of those complaints are never investigated.

“The employee who, in the public interest, has the personal courage to challenge illegality is a kind of public hero.”