Showing posts with label violation. Show all posts
Showing posts with label violation. Show all posts

Thursday, October 1, 2015

FDA will destroy banned imported drugs - Modern Healthcare

Updated June 16, 2025

The original link broke.

You can still read about this same topic on this FDA webpage:
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-imports

---  the original post follows below  ---

Read the full article: FDA will destroy banned imported drugs - Modern Healthcare Modern Healthcare business news, research, data and events:

"Federal regulators will begin destroying some medications that can't be imported into the U.S.​ because of quality concerns.

Beginning Oct. 15, the U.S. Food and Drug Administration will destroy a drug that wasn't allowed into the U.S. because it's been found to have been “adulterated, misbranded or unapproved” and in violation of the Food, Drug and Cosmetic Act. The policy covers a drug if the value of a single dose is $2,500 or less. "

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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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Thursday, November 7, 2013

Dietary Supplement Firms Still Violating Basic Manufacturing Rules - NPI

Updated September 4, 2024

The original link broke.

You can still read about the same topic here, on Natural Products Insider:
https://www.naturalproductsinsider.com/manufacturing/fda-still-finds-basic-gmp-violations-in-supplement-industry

---  the original post follows below  ---

Dietary Supplement Firms Still Violating Basic Manufacturing Rules - Natural Products Insider:

"FDA has been bringing down the hammer on one out of three dietary supplement firms for failing to comply with cGMPs. Through the first several months of fiscal year 2013, of the 350 cGMP inspections FDA originally designated and concluded as falling under Part 111, the agency's 19 district offices collectively classified 33 percent, or 117 businesses, as OAI (official action indicated)."

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