FDA is issuing this communication to ensure all parties understand FDA’s willingness to accept
private laboratory analytical results in electronic formats.
It is commonplace for Importers of products subject to detention without physical examination (DWPE) to submit laboratory analysis as testimony to overcome apparent violations. These laboratory analyses are typically provided in the form of third-party commercial laboratory (referred to as “private laboratories”) analytical reports to demonstrate compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and with current FDA regulations.
This communication is to inform all parties that FDA will accept private laboratory analytical reports in electronic formats, as well as hard-copy forms. Furthermore, this communication is to inform all parties that it is FDA’s preference for private laboratory analytical reports to be submitted in an electronic format for greater ease and speed of processing by FDA.
In general, private laboratory analytical reports should be submitted to FDA Districts as per established District contact points. Some Districts have set up special email accounts for the purpose of accepting private laboratory analytical reports and other testimony in the Detention and Hearing process. Absent any other instructions from the District handling the entry, submissions of testimony should be routed to the contact point(s) listed in the specific Notice of FDA Action referencing the detention of the entry/line.
Please note that, at this time, ITACS is not an acceptable means of submitting private laboratory analytical reports. If and when future functionality allows for the submission of private laboratory analytical reports through ITACS, the importing community will be notified.
In the near future, FDA intends to automate its private laboratory analytical reports review processes. Once that is accomplished, FDA will be able to process private laboratory analytical reports submitted via electronic means in less time than is needed to process private laboratory analytical reports submitted in hard copy forms. Therefore, in order to avoid potential delays, private laboratory analytical reports should be submitted electronically.
All analyses conducted by private laboratories and the reports submitted for those analyses are expected to conform to the guidance found in FDA’s ORA Laboratory Manual, Volume III, Section 7, “Private Laboratory Guidance”, found at: http://www.fda.gov/downloads/ScienceResearch/FieldScience/LaboratoryManual/UCM092191.pdf
Questions involving the status of specific entries and/or the processing of specific entries should be directed to the FDA District covering the Port of Entry for the entry. FDA District contact information can be found at the following link: http://www.fda.gov/ForIndustry/ImportProgram/ucm319216.htm
Questions involving FDA import operations and/or FDA import policy in general should be directed to FDA’s Division of Import Operations at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov
Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be directed to the Office of Regulatory Science, at (301) 796-5992.