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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.
Disclaimer:This Alert has been
prepared and published for informational purposes only and is not
offered, nor should be construed, as legal advice. For more
information, please see the firm's
full disclaimer.
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Managing Investigations And Litigation Risk In The Food & Beverage Sector
