Until each of the violations are corrected and FDA has confirmed such corrections, FDA may withhold approval of new applications or supplements.
On August 20, 2019, the U.S. Food and Drug Administration announced that it had sent and posted a warning letter to an over-the-counter drug manufacturer citing “significant” violations of current good manufacturing practice (CGMP) and also issued a news release in connection with this letter. The letter was sent to NingBo Huize Commodity Co., Ltd., a China-based manufacturer of health and beauty products such as sunscreen lotion, shampoo, hand sanitizer and lip balm, following FDA’s inspection of the facility in March 2019. In particular, the warning letter, and concurrent press release and import alert, show that FDA continues to have significant concerns related to data integrity and will harshly sanction companies that falsify data.
The warning letter identifies FDA’s basis for concluding that NingBo has violated its CGMP obligations under 21 CFR, Parts 210 and 211, including failure to have adequate quality systems, data integrity issues, falsification of reports, as well its inability to provide records supporting CGMP requirements relating to the manufacture of certain drugs, including those relating to equipment qualification (under 21 CF 211.63); raw material qualification and active pharmaceutical ingredient testing (under 21 CF 211.84); and finished product and raw material testing qualification (under 21 CF 211.165). As a result of the CGMP failure, FDA considers all of NingBo’s drug products to be adulterated.
As concerns the issue of data integrity—which FDA defines as referring “to the completeness, consistency, and accuracy of data”—FDA stated in its warning letter that one of the managers of the NingBo facility inspected by FDA conceded to inspectors that certain documents provided to FDA had in fact been falsified “for the purpose of th[e] inspection.” To cure its data integrity shortcomings, FDA has instructed NingBo to undertake “a comprehensive investigation into the extent of the inaccuracies in data records and reporting” to be provided to FDA in response to its warning letter.
In addition, FDA informed NingBo that certain products that it manufactures—including the 30 ml and 60 ml sizes of its SPF 30 sunscreen lotion product—are “misbranded” under the Food Drug & Cosmetic Act because they did not include directions for use and lacked required warnings. As a result, “Introduction of such products into interstate commerce” is prohibited by federal law.
Beyond classifying certain manufactured products as misbranded, FDA has issued an import alert and informed NingBo that, until each of the violations are corrected and FDA has confirmed such corrections, FDA may withhold approval of new applications or supplements identifying NingBo as a manufacturer. Both of these outcomes highlight significant risks facing manufacturers who come under FDA scrutiny for CGMP and data integrity violations.
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