Blogs about: Warning Letter
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NEW ADDITION TO WARNING LETTERS’ “BOILERPLATE” PARAGRAPHS
CDER RESPONDS TO MANAGEMENT OF LACK OF AVAILABILITY OF FINISHED DRUG PRODUCT OR API Recently the FDA has added a new standardized paragraph to each of its Warning Letters for both Finished Drug Produc… more →
Barry A Friedman, PhD LLC
Draft of Warning Letter to Employee
wrote 1 day ago: To know how to issue warning letter to defaulting employee, click the following link: http://www.cit … more →
NEW ADDITION TO WARNING LETTERS' "BOILERPLATE" PARAGRAPHS
wrote 1 week ago: CDER RESPONDS TO MANAGEMENT OF LACK OF AVAILABILITY OF FINISHED DRUG PRODUCT OR API Recently the FDA … more →
IMPORT ALERT FINDING GREATER USAGE WITHIN FDA'S BAG OF "WEAPONS"
wrote 2 months ago: GULF PHARMACEUTICAL INDUSTRIES (02/23/12), NOBILUS ENT (03/07/12) and LABORATORIOS JALOMA S.A. de C. … more →
WINTAC LIMITED INDIA RECEIVES FDA WARNING LETTER (022312)
wrote 2 months ago: CITES ASEPTIC MANUFACTURING FACILITY FOR SIGNIFICANT cGMP VIOLATIONS Specific violations observed du … more →
Quality Problems & Drug Shortages At Manufacturing Plants, Are They Linked?
wrote 3 months ago: Federal regulators warned a major drug manufacturer about problems, including a disturbing issue inv … more →
Scott Veerkamp Received Warning Letter
wrote 4 months ago: Warning Letter To Scott Veerkamp From The Office Of The Indiana Attorney General… Warning Le … more →
FDA Warns DuPuy Company To Stop And Comply Or Face Consequences
wrote 4 months ago: Johnson & Johnson in the hot seat again, as the U.S. Food and Drug Administration (FDA) just iss … more →
The Cake Box recent FDA Warning Letter for rats & rodents
wrote 5 months ago: The president of The Cake Box in Lafayette California received an FDA Warning Letter recently for vi … more →
Pharma Petitions FDA for Binding Off-Label Rules
— 3 comments
wrote 10 months ago: Author: Mary Holloway Eliminating illegal off-label promotion while engaging in legal scientific dis … more →
Regulatory and Marketing Symbiosis from Concept to Commercialization (SLIDES)
wrote 11 months ago: Authors: Maureen Shaffer and Elsa Abruzzo Recently two Good Promotional Practices’ blog … more →
Happy Anniversary for FDA Bad Ad
wrote 11 months ago: Author: Mary Holloway In November 2010 we reported on the FDA’s Bad Ad Program, which asks physician … more →
CHINESE API MANUFACTURING FACILITIES RECEIVE WARNING LETTER (MARCH 30, 2011)
wrote 1 year ago: NINGBO SMART PHARMACEUTICAL RELEASE WITH INCOMPLETE C of As Comment The Ningbo Smart Pharmaceutical … more →
WARNING LETTER SANOFI AVENTIS DEUTSCHLAND GmbH
wrote 1 year ago: WARNING LETTER FEBRUARY 9, 2011 SANOFI AVENTIS DEUTSCHLAND GmbH (con’t) 2. Your firm has not … more →
PROPOSED CHANGES TO USP PET COMPOUNDING FEBRUARY 21, 2011
wrote 1 year ago: WEBINAR ON PROPOSED CHANGES TO USP<823> RADIOPHARMACEUTICALS FOR POSITRON EMISSION TOMOGRAPHY … more →
Steris Corporation Warning Letter February 9, 2011
— 1 comment
wrote 1 year ago: Warning Letter February 9, 2011 Steris Corporation “Chemical Indicators (Verify SixCess Class 6 Ch … more →
Baxter Healthcare Puerto Rico Warning Letter 1/20/11
wrote 1 year ago: Warning Letter January 20, 2011 Baxter Healthcare Puerto Rico 1. The Jayuya Facility (Puerto Rico) A … more →
Baxter Healthcare Puerto Rico Jayuya Warning Letter 1/20/2011
wrote 1 year ago: Warning Letter January 20, 2011 Baxter Healthcare Puerto Rico 1. The Jayuya Facility (Puerto Rico) A … more →
Baxter Healthcare Corp Puerto Rico Warning Letter - Just Issued
wrote 1 year ago: The FDA just announced the Warning Letter for Puerto Rico - Comments to follow Baxter Healthcare Co … more →
Baxter Receives Warning Letter Puerto Rico 1/27/11
wrote 1 year ago: Baxter Receives Warning Letter (1/27/11) Baxter received a FDA Warning Letter yesterday (January 27, … more →
