FDA’s Warning Letter Database now screens for COVID-19 Violations 

Posted by Joe Stefansky on May 11, 2020 in Alert, Industry News,

A public facing FDA Warning Letter Database exists regarding manufacturers that commit violations of U.S. Food and Drug Administration (FDA) regulations. Recently, this database began flagging organizations for COVID-19 related violations. Specifically, this database captures warning letters that the FDA previously sent out to implicated manufacturers. Issues that trigger a warning letter may include poor manufacturing practices, false product claims, or inaccurate directions for the use of a product.

Streamline Verify has been screening clients against this database and would like to draw attention to the FDA’s guidance to avoid COVID19-related violations in their new COVID-19 pages: Frequently Asked Questions and  Guidance Documents for Industry, FDA Staff and Other Stakeholders.

Notably, a new issue coming up repeatedly in the database’s subject header is related to Health Fraud, namely Unapproved and Misbranded Products Related to Coronavirus Disease 2019. Some products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. § 352.  Others are violating the introduction of products into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d).

As of today, the FDA Warnings Letter Database has excluded 51 entities due to a COVID-19 related concern. A required correction plan with directions and time frames are included in letter.

There is a lag time and the letter in the database may not be a timely reflection of the current regulatory status of the letter recipient. Upon notation from the manufacturer of the corrective actions, next the FDA will confirm the corrections made are sufficient. The letters may not contain regulatory information between the FDA and the letter recipient that occurred subsequently to the letter’s original sent date.

For more information about this database or FDA agency records, please see the page How to Make a Freedom of Information Act (FOIA) Request. As of 3/12/2020, to ensure timely logging, the FDA is asking that all requests be made via their online portal rather than by mail, fax, or courier.

About Joe Stefansky

About Joe Stefansky

Joe Stefansky has a keen sense of business opportunities in complex problems, using technology to transform difficulty into efficiency. The CEO and founder of Streamline Verify specializes in solving compliance, legal and administrative issues through intuitively designed software that reduces costs and saves time.

Related Articles

Some Medicaid Plans May Overstate Provider ...

October 28, 2022

Medicaid patient access to care has been a challenge for years. Many providers have historically opted to not participate in Medicaid because of the low reimbursement rates and the increased administr...

Deficit Reduction Act Compliance: Certification Requirements ...

November 9, 2022

Background on the DRA The federal Deficit Reduction Act of 2005 (DRA) included new requirements related to fraud, waste and abuse for Medicaid plans that received or made payments of $5 million dol...

OIG Updated Its Exclusion List Twice ...

August 24, 2018

This month a second update was made on the List of Excluded Individuals/Entities (LEIE). The Office of Inspector General (OIG) of the U.S. Department of Health & Human Services (HHS) confirmed thi...

Understanding OIG Exclusions

OIG Exclusions Screening Process

Exclusion FAQS

Quick OIG Exclusion Basics

Employing Excluded Individuals

Consequences to Employing an Excluded Individual

OIG Compliance Law

Laws and Publications on OIG Compliance

More Compliance Resources

The Verify Way!

We build the best, so you can perform at your best.

Trusted for Good Reason

  • ✓ Guaranteed accurate
  • ✓ Certified Secure
  • ✓ Audit Proof
  • ✓ Feature-rich reporting
  • ✓ Round the clock real-time-data
  • ✓ Processing fully automated

Security First

  • ✓ Cloud hosted
  • ✓ Encrypted data
  • ✓ Real-time backups

Trusted for Accuracy

  • ✓ Physical security
  • ✓ Restricted access
  • ✓ Single sign-on
  • ✓ Password security
  • ✓ Certified secure
  • ✓ Cross checking

HEALTHCARE ESTABLISHMENTS NATIONWIDE COUNT ON STREAMLINE VERIFY

5

60%

Average workload reduction by implementing the Streamline Verify program

5

10K

Establishments trust Streamline Verify nationwide

5

2011

Serving the healthcare industry’s unique compliance needs since 2011

5

24X

Setting standards with hourly synchronization to primary source data

[class^="wpforms-"]
[class^="wpforms-"]