Inspections and Audits

ARTICLES

FDA Officials Show Support for Risk-Based CAPA Strategy

FDA officials welcomed a risk-based approach to CAPA systems during a session at 2017 RAPS Regulatory Convergence, but cautioned that each CAPA investigation is unique. Read More

483 Roundup: FDA Cites Four Firms Over Complaints, CAPAs

The FDA issued Form 483s to four device manufacturers for issues ranging from responses to customer complaints to record-keeping. Read More

U.S., Brazil Add New Auditing Bodies for MDSAP

The FDA and Brazil’s National Surveillance Agency have added new auditing bodies to their list of organizations eligible to conduct quality management system audits for the Medical Device Single Audit Program. Read More

Warning Letter Roundup: FDA Flags Four Devicemakers

The FDA issued warning letters to four device manufacturers for a range of issues, including a failure to seek pre-market approval, to apply for modified intended uses, and quality violations. Read More

EpiPen Manufacturer Bungled Response to Complaints of Failures, FDA Says

A company that manufactures EpiPens for Mylan neglected to follow up on hundreds of complaints that the epinephrine injectors failed to operate during... Read More

483 Roundup: FDA Cites Three Device Firms for CAPAs, Complaints

The FDA issued Form 483 reports to three devicemakers over inadequate CAPAs, complaint handling and other deficiencies. Read More

483 Roundup: FDA Cites Three Firms for Quality, Documentation Failures

The FDA issued Form 483 reports to three devicemakers over inadequate quality procedures and documentation. Read More

President Signs Device User Fee Renewal Bill

A bill reauthorizing the FDA’s drug and medical device user fees for the next five years became law Aug.18 when President Trump signed it. Read More

483 Roundup: FDA Flags Six Device Firms for GMP, Other Deficiencies

The FDA found a wide range of GMP and other violations during inspections of six devicemakers. Read More

483 Roundup: FDA Finds Shortfalls at Four Device Facilities

The FDA found numerous GMP and other violations during inspections of four device manufacturing facilities. Read More