Subscribe
  
IPQ Inside the global regulatory dialogue

Your Search Results

Wave of FDA Warning Letters to Injectable Compounders in Q1 2014 Follows 2013 Inspection Blitz and Legislative Empowerment; Recipients Among Those Applying for Outsourcing Status

A bolus of FDA warning letters to injectable compounding operations in the first quarter of 2014 has followed in the wake of the agency’s 2013 inspection blitz of high-volume sterile pharmacy compounding operations nationwide and legislative empowerment through the Drug Quality and Safety Act (DQSA), signed into law in November....

DQSA Title I Cited in Warning Letter to Pharmacy Compounder

A warning letter issued to Triangle Compounding Pharmacy is the first to cite Title 1 compounding provisions of the Drug Quality Security Act (IPQ December 28 2013). The letter, issued in the wake of a Feb./March 2013 inspection states that the sterile drug compounder does not “qualify for the exemptions in section 503A of the […]

Hamburg Addresses Drug Quality Regulation During India Visit

In mid-February, FDA Commissioner Margaret Hamburg traveled to India to meet with government officials on quality and other regulatory topics. This visit included the signing of a “Statement of Intention” to clarify the points on which both countries will cooperate, such as: ● sharing of CGMP compliance and facility information, ● India observing FDA inspections, […]

China Agrees to House More FDA Investigators

Chinese officials have cleared the way for FDA to station ten additional drug and device investigators in China. The FDA investigators will work out of the U.S. embassy and will have diplomatic privileges and immunities, Bloomberg reports.

FDASIA Section 707 Draft Guidance on Obstructing Inspections Draws Industry Comments; Investigator Subjectivity Among Issues Raised

FDA’s new draft guidance on “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection” has drawn some industry concern regarding the degree of subjectivity it affords investigators in determining when the lines have been crossed....

FDA Seeking Industry Input on Quality Metrics to Help Rationalize Its Review and Inspection System

FDA is proposing that the application of the right quality metrics could help create a more flexible and rationalized review and inspection system and is asking for industry input on what metrics would provide the most effective leverage....

Compounder Recalls, 483s and Warning Letters Continue in Wake of FDA Inspection Blitz

The wave of recalls of contaminated preparations and FDA-483s is continuing as FDA’s extensive inspection blitz of compounding pharmacies across the US hits the four-month mark....

Pharmacy Compounding Will Remain Center Stage as FDA’s Focus Intensifies on Drug Quality, Hamburg Tells FDLI

Pharmacy compounding will remain center stage as FDA’s focus on drug quality continues to intensify, FDA Commissioner Margaret Hamburg told attendees at the 2013 Food and Drug Law Institute (FDLI) Annual Conference in late April in Washington, D.C....

FDA and EU Inspectors Draw Insight at Contract Manufacturers Into GMP Enforcement/Drug Shortage Crosscurrents

U.S. and European health agency inspectors are gaining more insights during their inspections of contract manufacturers into the complexities of balancing GMP enforcement with drug shortage prevention....

FDA Inspection Blitz Reveals Weakness in Sterile Practices at Large Compounders

A review of the initial results from an inspection blitz of about 30 high-volume sterile pharmacy compounding operations nationwide launched by FDA in late February shows a clear pattern of weakness in their sterile practices including environmental monitoring, gowning, personnel practices and sterility/endotoxin testing....
Pages: Prev 1 2 3 4 5 6 7 Next

Subscription Benefits

SUBSCRIBE TODAY and get 24/7 access to the IPQ family of publications:

.
● “In the News” — breaking stories on our website

● “News Alerts” — sent via email

● “Monthly Updates” — the key CMC and GMP developments in the US, Europe and internationally

● “Special Reports” — in-depth analysis of specific, emerging issues of regulator/industry concern

Documents and Archives — Live links to all the documents referenced in our stories and full access to IPQ’s valuable archive library

.

 

CLICK HERE  for the IPQ Monthly Update – July 2021 in Review


IPQ takes its readers from:

● the headlines to the forces driving them

● regulations and policies to their underlying intent

● the pieces of the puzzle to their interconnection

● requirements to implementation pathways

● random data to critical trends

● the sidelines to helping shape the outcome

● compliance problems to proactive quality tools

● information to intelligence

.

©2021 IPQ Publications