The Five W’s of Adverse Event Reporting for OTC Drugs
The Dietary Supplement and Nonprescription Drug Consumer Protection Act amended the FFDCA to subject those OTC drugs marketed without an approved NDA or ANDA to OTC drug reporting requirements, which had previously only applied to those OTC drugs with an approved...
FDAImports.com at the Boston Seafood Show 2014
FDA has recently begun applying Import Alert 99-30 to breaded seafood from China. That import alert relates to melamine in dairy products and foods with dairy-based ingredients. This is an unprecedented action. FDA has previously only applied Import Alert 99-30 to...
Import Alert 99-30: Now For Seafood Too?
The seafood industry should start preparing for greater FDA scrutiny and interference with seafood products from China. The industry is quite familiar with FDA’s Import Alert 16-131, which requires testing all aquaculture from China for unapproved veterinary drugs...
cGMP Violations: Don’t Learn it the Hard Way
Intending to close the frequency gap between foreign and domestic inspections, FDA has been increasing its foreign inspections, especially at drug plants in India. India is FDA’s current top priority, as it has the largest number of drug manufacturers and is a major...
Warning Letter for Seafood Facility – Watch Out!
FDA recently issued a Warning Letter to a seafood facility in Hawaii, citing five major issues that the firm must address: controlling pathogenic bacteria growth resulting from time/temperature abuse, controlling allergens at the packing/wrapping stage, having an...
Your SOPs and the UDI Regulations: December 23 Deadline
Device manufacturers take note: Changes in regulations accompanying the Unique Device Identifier (UDI) regulation took effect on December 23, 2013. The new UDI regulations reach far and wide. In addition to creating a new regulation at 21 CFR 830, changes also...
Antibacterial Soaps: Can Makers Prove Them Effective?
Approximately 90% of “antibacterial” or “antimicrobial” soaps currently on the market are made with the active ingredient triclosan, a chemical known to kill bacteria. For obvious reasons, consumers generally consider these soaps more effective than plain soap and...
FDAImports.com at Natural Products Expo West 2014
FDAImports.com is excited to attend and participate in Natural Products Expo West again this year, meeting and talking with many industry members involved in bringing natural products to the United States market. We are looking forward to joining the discussion on...
Import Duties on Warm-Water Shrimp from India
Last month, FDAImports.com attended the Chennai Seafood Show, where we had the pleasure of meeting and talking with many members of the Indian seafood industry. The industry is very interested in finding clarification on duties, rebates, and preferential rates –...
FDAImports.com at the Chennai Seafood Show
FDAImports.com recently attended and presented at the 2014 India International Seafood Show in Chennai. Principal Rick Quinn and India Country Director Shanmugam Jayakumar met with processors, exporters, and industry members at the FDAImports.com booth, discussing the...