FDA publishes Hazard Analysis and Risk-Based Preventive Controls (HARPC)
Yesterday, September 10, 2015, FDA released the final rules for Preventive Controls on human and animal foods. This regulation has been a long time in coming, and will drastically change the landscape of food regulations for both domestic and foreign food facilities....
Still Waiting: FDA Not Yet Published the HARPC Final Rule
This week the Food and Drug Administration (FDA) was required to submit the final rule for the Hazard Analysis and Risk-Based Preventive Controls (HARPC) for publication in the Federal Register. According to FDA, this was completed on August 31, but curiously FDA has...
5 Things You Should Know About Import Alerts
Don’t Wait to Act Until FDA Adds the Company to Import Alert Waiting until you get red-listed before identifying what happened and fixing it is a big time-and-money mistake. However, if you wait until your company is added to an import alert, you will likely have a...
Special Cases for UDI Requirements
Multiple-Use Devices Devices intended for multiple use, and intended to be reprocessed before each use, will likely have their original packaging discarded when the device is first used. Therefore, these devices must bear a Unique Device Identifier (UDI) as a...
Unique Device Identifier Deadline: September 24, 2015 – Are You Ready?
Update 8/27/2018 Unique Device Identifier Deadlines – 2018 Medical device labeling requirements differ from other regulated products because they are required to include a special barcode, a Unique Device Identifier, that is unique to each medical device. Obtaining an...
FDA Import Screening Down, Down, Down
FDA’s electronic import entry review systems will be down for major upgrades from this Saturday, May 9, 2015 at 1:00 am EDT until Sunday, May 10 at 1:00 am EDT. This will impact primarily food imports and perishable imports. In addition to Prior Notices submitted...
FSVP is Fast Approaching: Are You Ready?
UPDATE 07-07-2017: The next compliance date is in March 2018. Importers should spend this time developing the programs as it takes time to work with Foreign Suppliers to build a robust FSVP program. A recent report in Peru indicated that the regulatory system which is...
FDA Cancels Swordfish Import Alert 16-08
Worldwide Ramifications Unclear Until FDA Releases New Import Criteria for Methyl Mercury The U.S. Food and Drug Administration (FDA) confirmed today that the agency cancelled Import Alert number 16-08. According to FDAImports.com's daily-tracking records on...
FDAImports.com Expands Services in Australia and Asia
FDAImports.com is excited to announce that Principal Rick Quinn, Esq. recently relocated to Australia. Mr. Quinn’s strategic move will allow the firm to build alliances with clients, associations, and service providers in the Australasia region, and allow the firm to...
Allegation of Wrong Identity for Dietary Supplements Means Increased FDA Scrutiny for the Whole Industry
The New York attorney general’s office is alleging that the store brand dietary supplements sold by four major retailers are misbranded and adulterated. New York asserts that the products did not contain the declared dietary ingredients, in many cases only contained...