Long Island Import Export Association Fda Questions (10/6/14)
LONG ISLAND IMPORT EXPORT ASSOCIATION --- FDA QUESTIONS (10/6/14)
1. Should the broker always get the FDA product code from the customer and which commodities are more prone to having errors?
Answer:
The broker in consultation with the importer and possibly the manufacturer should collaborate in determining the most suitable product code. Food, Biologics, Drug and Device products are complicated and close collaboration are necessary between the broker and their customer to develop the product code. Brokers should obtain photographic documentation of the label especially in foods reflecting the ingredient statement to make a definitive determination of the product code.
The broker is responsible for verifying that the product code provided by the customer is a suitable product code associated with the information reflected on the commercial invoice or other documents such as certificates of origin.
Deficiencies are reflected across all industry codes especially raw ambient, raw fresh refrigerated and raw fresh frozen articles. Additionally, commercially sterile foods, aseptic packed foods and acidified foods are not using the most accurate process indicator code.
The inappropriate use of the product number “99” when there are more suitable numbers. The inappropriate use of the letter designation “Y” for the subclass and process indicator code when there is a more suitable code.
Brokers need to consult the FDA product code builder tutorial so they can develop the appropriate questions for the interview with the customer.
2.FDA Filer Evaluations -the FDA makes it necessary to have a grade of less than 10% error rating.After a failing grade will the FDA start the process of putting a company on dual filing system?
Correction:
Error rate of 10% or less
Answer:
Yes, the filer will be provided with a written list of the identified errors and the FDA’s proposed corrections of those errors. The broker will have a minimum of at least 3 evaluations to correct the deficiencies unless there is suspected intentional fraud. The broker is expected to develop a written corrective action plan to address the deficiencies. These evaluations are not intended to identify each and every potential error. The brokers should develop internal quality assurance systems and programs to insure the most accurate and current information is provided to FDA for each entry transmitted.
Where does FDA find most of the entry errors?
Answer:
Manufacturer’s name and address in whole or in part
Shippers name and address in whole or part
Not reflecting the name and address of the individual or entity that appears on the Master or House Bill of Lading in the shipper/exporter field of the document
The product code portion that represents the process indicator code, the sub-class and the product number
Combining different products into one line when these products have different product codes such as swordfish vs. tuna
Product coding aqua-culture fish as wild harvest fish
Product coding Low acid or acidified foods which requires a process indicator code of either “E”, “F” or “I” with the process indicator code “T” for packaged foods
Employing the product number “99”, the subclass and process indicator code “Y” when there are more suitable options
Product coding an article than may be in more than one industry code such as toothpaste which may be a cosmetic or an over the counter drug depending on the ingredients and potential claims reflected in the ingredient statement and not selecting the most appropriate industry code in this illustration it would be a drug industry code
Not selecting the most appropriate product code such selecting a more boarder code and not selecting the most specific code
Not Transmitting and FDA regulated article
3. Misbranding is a common issue for many importers and we are looking to prevent the holds and detentions.
Please clarify which commodity is being referenced. I suspect the question is in reference to FFDCA Sec. 502(f)(1) however there are also many FFDCA SEC 403 detentions. However, any discussion regarding prevention of detentions should be addressed by an outreach session.
4. What section of the CFR 21 does the FDA use for the documentation request on an import of an API? Does the CFR states the type of documents required such as end user documentation, besides the firm registration and NDC number? Or this is an internal request?
Answer:
The related CFR is 21 CFR Part 201, Subpart D (exemptions from adequate for use) and specifically 201.122 and/or 201.120.
Document requests are executed by entry review or compliance branch when the information reflected in the electronic transmission is insufficient to make an entry determination. The CFR does not specifically identify the types of documents or other written or verbal testimony that may be provided at the time of entry or to overcome the appearance of a violation.The JFK Brokers association may be in possession of the “The best Practices for Importing API”.
5. Why there is such difference on documentation request between different compliance officers? Does FDA follows guidelines for API’s and are those guidelines available to the import community?
Answer:
The reason why the documentation requested may differ is because of the variation in intended use and the variation in entry data and documentation submitted that may result in questions, and therefore subsequent documentation/informationrequests, about the end use. Therefore, regulatory discretion is needed to determine what information/documentation gaps need to be addressed regarding the supply chain parties and the ultimate end use. Generally, documentation would include copies of current shipment labels and accompanying approved end use documentation should be sufficient to connect all the supply chain dots, includingthe amount of API transacted, from API manufacturer to finished drug manufacturer.
If you would like to arrange for a compliance based outreach session on the topic of detention resolution for drug shipments, please contact Anna Alexander, DCB.
6. Before we ship a product, we would like to make sure we know which documents and information are needed so that we do not have any FDA holds at the time of entry. Who can we contact at the FDA for this information because I had e-mailed the NY FDA Detention Office and never received a response?
Answer:
FDA does not provide pre-clearance; additionally we can only provide general information in this format. The suggested documents needed are the CBP forms, shipping records such as master and house bills of lading, commercial invoices, packing lists, certificates of origin and any other such document which may assist in the entry process. Insuring the following is current: Food Facility Registration Number and registration and listing information for devices, LACF, drugs and etc.
Send emails to the NYK Detention mailbox if and only if the email is regarding a detention and there is a problem with ITACS. Documentation to address detentions should be sent via ITACS.
7. Is there any way to verify a manufacturer's FDA registration with the FDA as entries can be placed on hold if the FDA registration is not correct? We always ask for the FDA Registration screenshot or Certificate but there are times when the supplier states they only have the number.
Answer:
FDA does not provide the trade with the name and address of the firm associated with the Food Facility Registration number because it is a security element. The importer is responsible for obtaining that information.
8. We have had a very bad experience with a particular FDA Compliance Officer in which we would contact the officer with our questions and leave dozens of messages on their voicemail and never receive a phone call back. We would then e-mail the officer and after several days of waiting, the officer would reply only by e-mail. We had to re-export a container twice because of the same compliance officer and we found no fault in the product. If the same Compliance Officer is assigned to an entry, is it possible to request a change in Compliance Officer so there are no delays or issues.
Answer:
Email is the preferable form of communication with COs regarding detentions. Email provides for written documentation and for correspondence that helps to minimize misunderstandings and misinterpretations that more frequently occur with verbal communications. Use of email also allows the CO to research a response if needed, and allows the CO to better manage his or her time. Phone correspondence should only be used if absolutely necessary and when email communication has been exhausted and issues remain unresolved. Understand that given the volume of detentions, phone correspondence for COs is not usually practical. Preventing detentions is the best approach and you should contact Anna Alexander, DCB to arrange for an outreach session to address this topic.
As far as a pattern of problems that is specific to a particular CO, you should contact the CO’s supervisor, Anna Alexander, DCB to discuss the problem.
9.What is the expiration date for an FDA Registration? According to the FDA website, every food facility is required to file in each even numbered year. If a food facility files during an odd numbered year like 2013, is the food facility required to file again in 2014?
For example, one of our shippers received a Registrar Certificate dated 11/19/13. Will this FDA registration expire at the end on 12/31/14 or 12/19/14?
Answer:
2014 Food Facility Biennial Registration Renewal
See CSMS# 14-00618- FDA Food Facility Registration Renewal
The renewal period is October 1, 2014 12:01am through December 31, 2014 12:59pm
Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d] requires food facilities that are required to register with FDA to renew such registrations during the period beginning on October 1 and ending on December 31 of each even-numbered year.
Please be advised that “updating” your registration is a different function than “renewing” your registration. During the renewal period, you will not see the “Update” button listed on the FFRM main menu, until the registration is renewed. If a registration is not renewed by 11:59 PM on December 31, 2014, the registration is considered expired and will be removed from your account. If you have any further questions please contact the FURLS Helpdesk: by phone 1-800-216-7331 or 301-575-0156; or by email .
10.Who do we need to contact to arrange a phone conference between my client in the UK and FDA regarding importing sunglasses into the USA? They are buying the sunglasses from multiple third party vendors and not direct from the factory. They do not receive a copy of the factory invoice and are constantly getting detention notices from FDA for Misbranding. I have spoken to the compliance officer who provided direction for the importer but the importer would like to discuss in detail the requirements that they need to follow so that their shipments are not held for detention.
Answer:
Contact the Director of Compliance and or the Special Assistant to the Compliance Branch Director for NYK-DO.
11.I would like to know if there is a correction process in the rare instance a mistake is made on the transmission of the entry. In these cases it has been my opinion that the shipments will go on hold for weeks or months and we are not able to contact anyone at the FDA that can assist on the correction.
FYI – We have found the correction process to be easier and quicker in many of the other FDA ports around the country.
Answer:
It is not possible to make corrections to an entry that may contain inadvertent typographical errors or missing or mis-leading information such as registration and listing information for human and animal drugs, biologics, medical devices, radiological devices and low acid canned foods. The entry review supervisor needs to be contacted before an initial decision is executed by a member of the review staff. If that can be accomplished, the corrected information needs to be supplied with a short explanation for the cause of the deficiency.
However, if the entry may have been identified for potential detention because of the typographical or missing or mis-leading information, then the information will be needed to be provided to the specific compliance officer to overcome the appearance of the violation
12. Will the FDA meet with individual customers upon request? We have been advised that requests for meetings have been denied.
Answer:
The NYK-DO Downstate Import Operations Branch routinely conducts meetings at the FDA Office located in Jamaica, NY with brokers and their customers. The branch will attempt to resolve any issues first by telephonic means if at all possible. The meetings are arranged with the NYK-DO Downstate Director, Import Operations or the Special Assistant to the Downstate Director, Import Operations.
The above answers are not intended to be all inclusive.
1