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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 […]

We took a snapshot of the 7 warning letters the FDA sent to food companies last month. Food violations ranged from failing to exclude rodents from site tofailing to have an HACCP plan. From companies in New York to Thailand, here they are: Elwood International, Inc., Copiague, NY – violations include:Failed to exclude pests from […]

It’s violation study time, and our GMP expert has extracted the key documents from this week’s global headlines. To note is Operation Pangea XI as well as Europe’s multiple reports of GMP non-compliance. DRUGS: Cipla Limited received a 1-page, 2-observation 483 at the close of the inspection on September 28th 2018. Observations include:The commercial batch record […]

November is right around the corner, and FDAzilla is starting it off right. We will be at the ISPE Annual Conference in Philadelphia! This conference & expo will not disappoint: there is a world-class speaker roster that covers the FDA and the CDER office. What is particularly exciting for us at FDAzilla are the speakers […]

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=30] Like this & want more? Sign up to get […]

FDA posted 6 warning letters this week including: 1 issued to a pharmaceutical company in South Korea1 issued to a clinical trial investigator in California BIORESEARCH MONITORING: Ignatius P Godoy, M.D. (Paramount, CA) receive a warning letter based on the outcome of a BIMO inspection for a clinical study ending June 8th, 2018. The study […]

What does it even mean to officially respond to a 483 and, better yet, how can a 483 be avoided altogether? The answer is basically split into 3 parts: The Pre-ResponseThe Response ItselfThe Post-Response 1. The Pre-Response You can talk directly with the inspectors during and after the inspection to clarify points and understand their […]