Colorado Devicemaker Cited for Lack of Acceptance Criteria September 26, 2019 The investigator said that the firm had no documentation defining the actual acceptance criteria. Read More
FDA Calls Out Florida Contract Manufacturer for Complaint Handling September 24, 2019 The complaint procedure had no requirements for investigating complaints without a lot number. Read More
California Devicemaker Slammed for Labeling Activities, Validation September 24, 2019 The firm didn’t put in place written procedures for labeling of its FemCap devices. Read More
Texas Devicemaker Scolded for Software Validation, Design Reviews September 23, 2019 The firm failed to maintain records of design reviews. Read More
Contract Manufacturer Cited for Procedural Issues September 23, 2019 The facility’s records showed that a class II component tension screw was distributed despite the failure to follow procedures. Read More
FDA Cites German Devicemaker for MDRs, Software Validation September 20, 2019 The facility used the unvalidated software for device history records, traceability and other quality management activities. Read More
Lax Quality Observed at Device Facility in China September 20, 2019 The company failed to investigate a customer complaint about a malfunctioning device. Read More
Tennessee Firm Hit for Inadequate Procedures September 18, 2019 The specification developer failed to document in the design history file that design output met design input requirements. Read More
New Life Cited for Process Control Issues, Lack of CAPAs September 18, 2019 The facility also lacked procedures to ensure that equipment was routinely calibrated. Read More
Lusys Laboratories Slammed for Host of Violations in 483 September 17, 2019 Design control procedures didn’t include instructions for design validations. Read More
FDA Warns Indiana Devicemaker for Validation Failures September 16, 2019 Problems identified included failure to validate or verify design changes. Read More
483 Roundup: FDA Flags Six Firms for GMP, Other failures September 16, 2019 The FDA cited six devicemakers for problems with complaint procedures, change controls and quality oversight, among other deficiencies. Read More