Seizure is always an interesting topic to explore. The doctor finds the concept of seizure fascinating, especially when it results in the government performing the actual taking of violative medical devices. Thank God it doesn’t happen too often.
It is Dr. D’s humble opinion that if a device manufacturer has had product seized due to compliance issues or egregious violations of the Act, then their quality and regulatory organizations must be run by “addlepated” (look-it-up) idiots. For this week’s guidance the doctor will provide some insight into the concept of Product Seizure. Now granted, the seizure process is just a tiny bit more complex than having U.S. Marshalls kicking in the doors and backing up and loading the proverbial turn-up truck. However, make no mistake seizure is one of the more powerful tools in the FDA’s compliance tool chest. They have ways of making you comply. Enjoy.
FDA’s definition of Seizure
A seizure is a civil court action against a specific quantity of goods which enables FDA to remove these goods from commercial channels. After seizure, no one may tamper with the goods except by permission of the court. The court usually gives the owner or claimant of the seized merchandise approximately 30 days to decide a course of action. If they take no action, the court will recommend disposal of the goods. If the owner decides to contest the government’s charges, the court will schedule the case for trial. A third option allows the owner of the goods to request permission of the court to bring the goods into compliance with the law. The owner of the goods is required to provide a bond (security deposit) to assure that they will perform the orders of the court, and the owner must pay for FDA supervision of any activities by the company to bring the goods into compliance.
Typical FDA Warning Letter Clause
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Product seizures
Product seizure is a powerful enforcement tool, available to FDA, used to address compliance issues or quickly block medical devices that violate the Act or are deemed not to be safe and effective in their intended use. The good news is FDA cannot just kick-in the doors. The agency needs a court order to proceed with the product seizure and eventual impounding of violative devices. Conversely, the government does not have to reimburse medical device manufacturers for the product seized. The bottom line is simple, just comply baby.
To give the readers a better idea of how frequently product seizures are employed by FDA, Table 1.0 contains a breakdown of product seizures. In most cases, the product seizures are warranted in protecting the health of the general public. However, in one highly-publicized case, industry experts believe the FDA may have over-reacted.
|
Year
|
Number of Product Seizures
|
|
2009
|
8
|
|
2010
|
10
|
|
2011
|
15
|
|
2012
|
8
|
An example of the potential over reaction of FDA’s seizure process can be viewed in a highly-visible product seizure case from 2007 when the agency seized all implantable medical devices from a New Jersey-based medical device manufacturer in April of 2007. FDA claimed the seizure was driven by the identification of significant deficiencies noted during a plant inspection. FDA warned Shelhigh, Inc. of the consequences associated with their failure to address violations noted during a previous inspection. Although there was a few minor compliance issues noted during the Shelhigh inspection, some device industry experts believe FDA’s actions were not warranted. In fact, there was an underlying concern of the agency’s ability to act with impunity. Eventually, Shelhigh and FDA agreed to an out-of-court settlement.
Takeaways
For this week’s guidance, the doctor will leave the readers with just one takeaway. Common sense precludes the need for any relationship with FDA to sour to the point when a product seizure becomes eminent. The FDA is usually a reasonable agency to work with when a good-faith effort is being made to sustain quality and regulatory compliance. If observational deficiencies are noted during an inspection and a Form 483 is issued, address the darn deficiencies. Failure to do so will result in a Warning Letter and additional requests to respond to FDA will result in an eventual visit to the courts. In closing, thank you again for joining Dr. D and I hope you find value in the guidance provided. Until the next installment of DG – cheers from Dr. D. and best wishes for continued professional success.
- Code of Federal Regulation. (2013, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
- Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
- FDA – U.S. Food and Drug Administration Website. (2013, June). Warning letters. Retrieved July 18, 2013, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/
- FDA Guidance Document (2013, July). Definition of Seizure. Retrieved July 18, 2013, from http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094529.htm#seizure
- FDA Seizes All Medical Products From N.J. Device Manufacturer for Significant Manufacturing Violations. (2007, April). FDA Website. Retrieved July 18, 2013, from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108893.htm
- Rossetti, A. (2008, December). Shelhigh: anatomy of an FDA medical device product seizure. The Legal Examiner. Retrieved July 18, 2013, from http://westpalmbeach.legalexaminer.com/medical-devices-implants/shelhigh-anatomy-of-an-fda-medical-device-products-seizure/
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About The Author
Dr. Christopher Joseph Devine
President
Dr. Christopher Joseph Devine is the President of Devine Guidance International, a consulting firm specializing in providing solutions for regulatory compliance, quality, supplier management, and supply-chain issues facing the device industry. Dr. Devine has 32 years of experience in quality assurance, regulatory compliance and program management. He is a senior member of the American Society for Quality (ASQ), a member of the Regulatory Affairs Professionals Society (RAPS), and a member of the Project Management Institute, and resides on several technical advisory boards. Dr. Devine received his doctorate from Northcentral University, with his doctoral dissertation titled, “Exploring the Effectiveness of Defensive-Receiving Inspection for Medical Device Manufacturers: A Mixed-Method Study.” Dr. Devine holds a graduate degree in organizational management (MAOM) and an undergraduate degree in business management (BSBM).
