Facility Listing Errors and Missing Development Data Draw Withhold Recommendations From FDA’s NJ District

Facility listing errors on the application and a lack of availability of development data source documents during pre-approval inspections are causing the New Jersey District to recommend withholding drug approvals, its investigations branch director Myriam Sosa told DIA’s June Annual Meeting.

In 2009, fourteen withhold recommendations were issued in the New Jersey district:  ● three because the facility was withdrawn ● six due to no testing performed at the site, and ● five for lack of development data.

Sosa explained that a “facility withdrawn” withhold recommendation is made if a firm or testing laboratory is listed as part of an application but the sponsor decided it would not be used to support the application and did not update the application on file.  This category has also been used when the inspection team discovered an outside facility listed had no contract with the drug manufacturer.

A withhold recommendation for “no testing performed at the site” is given when the inspection team goes to a contract testing facility, for example, and discovers that the lab is not aware that it has been listed on the drug application.

The third category of NJ withhold recommendations stem from source documents for data cited in the application not being readily available for the inspection team to check against the application.

[More from Sosa on withhold recommendations and PAI findings is provided for subscribers here.]