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Sec. 820.1d Scope. |
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(d) Foreign
manufacturers. If a manufacturer who offers devices for import into the
United States refuses to permit or allow the completion of a Food and Drug
Administration (FDA) inspection of the foreign facility for the purpose of
determining compliance with this part, it shall appear for purposes of
section 801(a) of the act, that the methods used in, and the facilities and
controls used for, the design, manufacture, packaging, labeling, storage,
installation, or servicing of any devices produced at such facility that are
offered for import into the United States do not conform to the requirements
of section 520(f) of the act and this part and that the devices manufactured
at that facility are adulterated under section 501(h) of the act. Interpretation:
If a
foreign manufacturer denies the FDA access to their foreign facility (for an
audit) the manufacturer risks having their products labeled as adulterated by
the FDA. Such products will be
banned from entering the US and may be the subject of a recall.
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Reference: www.FDA.gov The information provided here is for "public consumption" and is open to interpretation. MedicalDeviceSchool.com is not responsible for the content or the accuracy of the information. For all official interpretation and accuracy we ask that you consult the FDA's website directly and that you consult with your legal and regulatory experts on all matters of interpretation. |
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