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We took a snapshot of the 9 warning letters the FDA sent to food companies last month. Food violations ranged from misbranding products to failure of eliminating rodents. From companies across the country, here they are: Gold Star Distribution, Inc., Minneapolis, MN – violations include but are not limited to:Failed to take effective measures to […]

In the past week, we added the following 483s to our database of 27,500+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Can’t find the 483 you’re looking for? Here’s a FREE company report instead. [supsystic-tables id=40] Like this & want more? Sign up to get […]

This week the FDA posted 4 new warning letters: 1 to a cell/tissue product manufacturer1 to a firm for failure to list1 to a compounding pharmacy1 to a device manufacturer CELL AND TISSUE PRODUCTS: StemGenex Biologic Laboratories, LLC (San Diego, CA) received a warning letter on October 31st 2018 based on the outcome of an […]

From contaminated toothpaste on the shelves to “lack of sterility” across the board, here are last week’s recalls. An FDA update a day keeps the recalls away. Get free recall, 483, & Warning Letter reports. DRUG RECALLS: [supsystic-tables id=36] UNCLASSIFIED RECALLS: [supsystic-tables id=37] Like this & want more? Sign up to get free […]

In the past week, we added the following 483s to our database of 27,500+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. Can’t find the 483 you’re looking for? Here’s a FREE company report instead. [supsystic-tables id=33] Like this & want more? Sign up to get […]

This was an exceptionally light week of only 2 published warning letters, 1 of which was a compounding pharmacy which we cover below. COMPOUNDING PHARMACY: Vital Rx, Inc. dba Atlantic Pharmacy and Compounding received a warning letter on Sept 26th2018 based on the outcome of an inspection ending July 20th 2017 (not a typo). Violations […]

FDA published 13 warning letters this week including: 4 sent to device firms located outside the US1 sent to a compounding pharmacyAnd a GCP untitled letter CLINICAL, UNTITLED LETTER: A letter from Public Citizen to both Commissioner Gottlieb and the Director of the HHS Office for Human Research Protections along with a 483 issued to […]

Enforcement: Recalls:A handful of both classified and unclassifiedAmong the unclassified recalls are additional recalls of Valsartan-like APIs. Seems like this will be going on for a while!Class II and III recallsImport Alerts:Several import alerts for preventing FDA inspections Warning Letters:Drug Manufacturers: 2 warning letters including 1 issued to a PET drug manufacturerClinical Trial Investigator: 1 warning letterCompounding […]

In the past week, we added the following 483s to our database of 27,500+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store. This post is no longer available.

FDA posted 10 warning letters this week including: 8 citing unapproved or misbranded new drugs with problematic websites as the source of FDA’s information1 to a compounding pharmacy COMPOUNDING PHARMACY: Auro Pharmacies Inc (La Habra, CA) received a warning letter based on the outcome of an inspection ending June 29th 2017 (not a typo).Violations include […]