Inspections and Audits

ARTICLES

Inadequate Document Control Lands Stand Aid in Hot Water

The FDA flagged Stand Aid of Iowa in a Form 483 over shoddy document control, device history records and documentation of nonconforming product activities seen at its Sheldon, Iowa facility during an Oct. 22-23, 2018 inspection. Read More

Imaging Biometrics Cited for Complaint Investigation Records

The FDA hit Imaging Biometrics with a Form 483, calling the Elm Grove, Wisconsin healthcare software developer out for its medical device reporting procedure and complaint records. Read More

Ecleris Scolded for Procedural Issues

EUSA Global, doing business as Ecleris USA, drew a Form 483 after an FDA inspection revealed problems with CAPA procedures and management reviews, among other issues. Read More

China Introduces Routine Overseas Device Inspections

China’s National Medical Products Administration is increasing its scrutiny of foreign manufacturers and will begin routine, risk-based inspections of foreign facilities to confirm they are in compliance with Chinese regulations. Read More

483 Roundup: FDA Flags Three Firms for MDRs, Other Violations

The FDA cited three device companies for medical device reporting, corrective and preventive actions and other violations found during inspections. Read More

FDA Scolds New Jersey Devicemaker for CAPA Handling

The FDA hit Monmouth Junction, New Jersey device manufacturer Replication Medical with a Form 483 following an inspection that revealed issues with the firm’s documentation of corrective and preventive action activities and device history records. Read More

Hemodialysis Solution Maker Dinged for Recurring Quality Issues

A 12-item 483 documents a litany of quality system failures the FDA found at Diasol East of Watertown, Tenn., during an Aug. 7 to Aug. 22 inspection. Read More

Zevex Cited for Inadequate CAPA, Nonconforming Product Rework

Inadequate corrective and preventive action procedures and improper procedures for rework of nonconforming product landed devicemaker Zevex in hot water with the FDA following a Sept. 4 to Sept. 17 inspection of its Salt Lake City, Utah plant. Read More

Wound Dressing Manufacturer Falls Short on Quality Requirements

Devicemaker Winfield Laboratories was unable to produce quality control documentation for its N-Terface dressing, a Sept. 24 to Sept. 25 FDA inspection of the Richardson, Texas, facility revealed. Read More

Surgical Instrument Maker Racks Up 11-item 483

Lax medical device reporting and CAPA procedures as well as a host of other quality issues were uncovered during a July 31 to Aug. 2 FDA inspection of LED Intellectual Properties’ Irvine, Calif. facility. Read More