Audits and Inspections

The agency sent a warning letter to Vista Pharmaceuticals Limited for CGMP failures related to equipment cleaning and process control.

FDA sent a warning letter to Shandong Analysis and Test Center for CGMP violations including data integrity issues and insufficient testing procedures.

The opening presentation gives the company a chance to put their best foot forward, according to Siegfried Schmitt, principal at PAREXEL.

This article presents a general strategy for authorship of deviation investigations, with primary focus on regulatory inspection success.

Yusef Manufacturing Laboratories, LLC received an FDA warning letter citing CGMP violations at its Clearfield, UT facility.

This article reviews experiences with the outcome of in-house audits, audits by third parties, and purchased audit reports.

FDA hopes to better use global resources and avoid duplicate inspections of foreign facilities.

The agency has issued more than 90 warning letters over the past 10 years to companies selling fraudulent cancer treatments.

FDA’s Office of Regional Affairs aims to implement Program Alignment initiative by May 15, 2017.

FDA puts Beijing Taiyang Pharmaceutical Industry Co. on import alert after company refuses access to inspectors.

The agency sent a warning letter to Cape Apothecary for adulterated drugs.

The agency cited the company for sterile manufacturing violations.

Sharing un-redacted inspection reports between FDA and EMA may reduce duplicate inspections of facilities.

The Office of Prescription Drug Promotion issues all-time low number of violation letters in 2015.

New program emphasizes quality, risk, and global collaboration.

Agency officials visit China to meet with Chinese regulators and industry representatives about keeping the pharma supply chain safe.

Drug manufacturers face added pressure and incentives for meeting new FDA compliance policies and priorities.

Supplier Audit Program Marks Progress

The rising incidence of medicine defects and shortages stemming from sub-standard manufacturing is forcing Europe to give higher prominence to more effective inspections procedures.

Third compounding pharmacy recalls products due to FDA inspection.

The authors present solutions based on a review of current service offerings and their audit experience.

FDA Updates List of Warning Letters

The contract provider needs to know as much as the NDA holder.

How to handle and respond to a consent decree.

Focusing on how risk affects the entire organization can improve the business bottom line.

Contract organizations must have highly organized teams and plans to accommodate today's audits.

Drug counterfeiting has become a major problem for the FDA today; a variety of solutions is needed.

Stiffer enforcement of quality standards aims to restore public confidence in agency actions.

There are several considerations to keep in mind when auditing an outsourcing provider.

After a strategic evaluation of what activities to outsource, sponsor companies should follow key guidelines for selecting and auditing a provider and preparing quality agreements.