FDA

Question:Has anyone in the Pharma/Biotech/Medical device industry seen an increase in FDA Holds?

Question:I work for an importer/exporter of industrial lifting equipment. Upon import, some of our goods are flagged for potential FDA reporting. We do import some products with lasers, leds and radiation emitting products. Is there a worksheet that someone would be willing to share as to how they determine if the product needs an FDA […]

Question:Regarding Marking Requirements with a Twist (for CBP and FDA Purposes) I work for a USA company.  Recently our Canada office placed an order with our Mexico office (bear in mind the USA is not involved in the transaction).  The Canada office purchases some bulk foodstuff from Mexico and asks Mexico to ship to a […]

Question: We have been trying to import a few different types of products that havebeen flagged FD2 by the FDA based on the product’s Harmonized Tariff Schedulecode. All of our products are intended for “Research Use Only” (as we are a Biotechcompany) and should not be regulated by the FDA.  Because of the FD2 Flag,our […]

Question:We have been trying to import a few different types of products that have been flagged FD2 by the FDA based on the product’s Harmonized Tariff Schedule code. All of our products are intended for “Research Use Only” (as we are a Biotech company) and should not be regulated by the FDA.  Because of the […]

Question:Am seeing increase in FDA inspections & holds. My customs broker tells me he’s seeing it across the board and we are not being singled out. Through rumor mill I’m told part of the reason is FDA’s fiscal year starts Oct 1 and now that they have the budget for lab/inspection they are firing on […]

Question: Do most that work in the area of importing investigational drug products deal with their Regulatory Project Manager assigned by the FDA to the specific IND in regards to assistance with detailed import/export questions or to another specific contact?  Any agency specific contacts outside of the typical CDER Drug Information Specialists would be greatly […]

Question:Would anyone know how PREDICT handles foreign suppliers who are listed on import alerts for products they no longer produce? If, for example, a foreign supplier is on Import Alert 99-08 ( pesticides ) dating back to let’s say 1998 on a particular food item that they no longer produce and they’ve decided not to […]

Question:   My broker tells me I need to file a FDA 510K.  Never heard of the critter. Can’t say that I especially want to.  But, it looks like I need to hear about this thing need to. And the answers database comes back with a Zero.   So, here are my questions:   1 […]

Question: We’ve noticed a recent increase in FDA (food) exams on cargo arriving via the port of New York. Across the board on different products ( fruits to vegetables ) and different origins ( Europe, South America etc). Am curious to know if the membership is also seeing an increase. I know PREDICT is being […]

Question:Among the things I value in being a member of the ICPA is the community of practice established in reaching out to ask questions…even the embarrassing ones. With all the hoopla about the FDA’s Transparency Taskforce…I’m curious to know if I’m missing something or if I simply haven’t clicked the right link. As a responsible […]

Original Question: Am seeing increase in FDA inspections & holds. My customs broker tells me he’s seeing it across the board and we are not being singled out. Through rumor mill I’m told part of the reason is FDA’s fiscal year starts Oct 1 and now that they have the budget for lab/inspection they are […]