Thursday, November 20, 2014

FDA Law Blog: DOJ Announces Another GMP Consent Decree for a Dietary Supplement Manufacturer

Read the full article: FDA Law Blog: DOJ Announces Another GMP Consent Decree for a Dietary Supplement Manufacturer:

"These cases show that FDA will aggressively pursue violators of the dietary supplement GMP requirements.   Because the consent decrees include a recall provision, a shut-down provision, and a requirement that FDA confirm that they are in compliance before they can reopen, the companies may well end up being put out of business permanently.

FDA does not bring a lot of injunction cases per year.  Four (or more) injunctions related to dietary supplement GMP suggests that this area is a high enforcement priority for the Agency."

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