Inspections and Audits

ARTICLES

483 Roundup: FDA Flags Three Devicemakers for GMP Lapses

Environmental Tectonics: A litany of good manufacturing practices lapses related to documentation and validation resulted in a seven-item Form 483 for Environmental Tectonics following an inspection of its Southampton, Pennsylvania facility. Read More

GSK Accuses Boehringer Ingelheim of Lying About Its COPD Inhalers

GlaxoSmithKline (GSK) hit Boehringer Ingelheim with a lawsuit in a Pennsylvania federal court accusing it of false advertising over its dry powder inhalers Ellipta and Diskus for chronic obstructive pulmonary disease (COPD). Read More

Georgia Attorney General Moves to Shutter BD Sterilization Plant

Georgia’s Attorney General filed a complaint to temporarily stop Becton, Dickinson from operating its Covington medical device sterilization facility “in an unlawful manner.” Read More

Contract Manufacturer Fails to Validate Equipment, Document Complaints

Failure to validate equipment and to establish CAPA procedures were among the QMS failures discovered during an FDA inspection of contract manufacturer Custom Milling Center’s Golden, Colorado facility. Read More

Device Re-Packager Lacks Procedures to Control Labeling, Device History

Alt Medical Devices’ Miami, Florida plant lacked procedures to control labeling activities and procedures for maintaining device history records to show that its devices were re-labeled and re-packaged according to specifications, FDA investigators found. Read More

Contract Manufacturer Cited for Validations, Nonconforming Product

Lax process validation, inadequate control of nonconforming product and failure to implement CAPA procedures were a few of the concerns the FDA highlighted during an inspection of Mark Two Engineering’s Miami Lakes, Florida facility. Read More

Validation, Procedures to Control Product Lax at IVD Lab

Procedures for accepting in-process product and procedures to control products that don’t conform to specifications were found to be lacking at Eurofins Viracor’s Lees Summit, Missouri, facility during a July 23-26 FDA inspection. Read More

Quality System Failures Found at Highland Industries

An FDA inspection of Highland Industries’ Cheraw, South Carolina facility uncovered numerous quality system deficiencies including missing validation and manufacturing records and test reports, along with a slew of other documentation failures. Read More

Surgical Lighting Firm Fails to Validate Design, Evaluate Complaints

Failure to validate design under defining conditions, poor documentation and failure to evaluate complaints were a few of the deficiencies observed during an FDA inspection of surgical lighting manufacturer Sunnex’s Charlotte, North Carolina facility. Read More

Lax Change Design Procedures Found at Vasamed

Failure to establish procedures for design changes and for acceptance of incoming product, were among the quality management lapses uncovered during a May 13-16 FDA inspection of Vasamed’s Eden Prairie, Minnesota plant. Read More