FDA Threatens Refusal of Entry, License Revocation for 3 Foreign Firms
The Food and Drug Administration posted warning letters that it has sent to companies from Taiwan, Indonesia, and France, threatening detention without physical examination and/or suspension and revocation of licenses. Indonesian device manufacturer Gooten Innolife Corp. (here) was told that…
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some of its products will remain on detention without physical examination until violations of current good manufacturing practices (CGMPs) are corrected, and French drug manufacturer Sanofi Pasteur (here) and (here) was threatened with license suspension and/or revocation for the same reason. The FDA told Indonesian fish processor P.T. Super Saku Bali (here) that its products may be refused entry through detention without physical determination if it doesn’t submit a revised Hazard Analysis and Critical Control Point (HACCP) plan.