Inspections and Audits

ARTICLES

How to Avoid Common CAPA Pitfalls

FDA inspection reports consistently show that the corrective and preventive action process is the biggest inspection problem for medical device facilities. And those who have to implement CAPAs have plenty of questions about how best to manage them. Read More

FDA Raps ADB Interests for Lack of CAPA, MDR Procedures

The FDA faulted ADB Interests for its MDR, complaint-handling and CAPA procedures. Read More

FDA Says Osteotech Must Improve Aseptic Processing, Investigations

The FDA cited Osteotech over inadequate sanitation and product deviation investigations. Read More

483 Roundup: FDA Targets Firms in Israel, The Netherlands, the U.S.

The FDA flagged two overseas facilities for inadequate medical device reporting and improper handling of nonconforming products, and cited a Florida devicemaker for numerous issues observed in a July inspection. Read More

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

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

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

UVLrx Therapeutics Flagged for IDE Violations

The FDA warned investigational medical device sponsor UVLrx Therapeutics for eight violations an FDA investigator observed during an inspection of its Florida facility from March 27 through April 4. Read More

FDA Cites Devicemaker Over MDR, GMP Violations

An inspection in March by the FDA of ELITech Group’s facility in Spankeren, The Netherlands prompted a warning letter after the device manufacturer failed to follow through with the promises made in response to a Form 483 report. Read More

FDA Warns German Device Firm Over Adulteration, Misbranding

German-based devicemaker DRG Instruments drew a warning letter from the FDA and the agency said it would refuse entry of the company’s medical devices to the U.S. market because they were adulterated and misbranded. Read More