Inspections News

Inspections News

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ARTICLES

Drug

FDA Warns Home Infusion Company

The FDA cited an Illinois provider of home infusion therapy for failing to meet sterile production standards, according to a warning letter from the agency. Read More
Drug

FDA Flags Outsourcer for Cybersecurity and Labeling Issues

The FDA cited a drug outsourcing facility in Bethlehem, Penn., for numerous compliance problems including inadequate computer security and lax labeling practices. Read More
Device

Pfizer EpiPen Manufacturer Draws Lengthy FDA Inspection Report

A Pfizer company was hit with a lengthy Form 483 from the FDA for 14 nonconformities. Read More
Device

FDA Flags GMP Problems at Indiana Devicemaker

Production workers at ATS Manufacturing threw out all of the nonconforming products they found and failed to document any follow-up activities over the course of nearly four years, an FDA investigator discovered in an August 14-18 inspection. Read More
Drug

FDA’s Morrison Says ORA Reorganization Will Mean More Foreign Inspections

The FDA pharmaceutical inspector of tomorrow will be more specialized by training and more likely to work abroad, a high-ranking agency official told an FDAnews regulatory conference. Read More
Drug

FDA Inspection Agreement With EU Frees Up Investigators for Rest of World

An FDA agreement to recognize good management practice reports from eight European countries, will allow the agency to reassign investigators to high-priority areas such as India and China, an official told an FDAnews inspections conference. Read More
Device

CDRH Eyes Quality, Program Alignment for 2018 Inspections

Moving into 2018, CDRH is focused on two main objectives to change how inspections of medical device manufacturing facilities are conducted — the case for quality and program alignment. Read More
Device

Health Canada Tweaks its MDSAP to Reduce Audit Times

Health Canada has made significant changes to its Medical Device Single Audit Program with the goal of reducing audit times. Read More
Drug

Falsified Test Results Net Chinese Company Warning Letter, Import Block

A Chinese maker of pain-relief balms and ointments falsified results of tests on its products and deflected FDA inspectors seeking to examine its laboratory, the FDA said in a warning letter. Read More
Drug

FDA Blocks Imports From South Korean OTC Manufacturer

The FDA blocked imports from a South Korean manufacturer of over-the-counter medical products after agency inspectors reported violations of current good management practices. Read More