Inspections and Audits

ARTICLES

Surgisil Warned for Unapproved Marketing of Facial Implant

Plano, Texas devicemaker Surgisil is in hot water with the FDA over its Perma Facial Implant, a device that is only cleared for cosmetic facial augmentation and augmentations in areas like the nose, chin and cheeks. Read More

Abaxis Gets Warning Letter for Adulterated Potassium Diagnostic

Abaxis was hit with an FDA warning letter over changes it made to a potassium assay used with its chemistry analyzer device that caused the product to be adulterated and misbranded. Read More

FDA Warns Boston’s TEI Biosciences Over ‘Systemic’ Quality Failures

The FDA issued a warning letter to TEI Biosciences’ for “systemic” quality failures the agency found during an Oct. 9 to Nov. 2, 2018, inspection of its Boston, Mass., facility. Read More

LC Medical Warned Over Validations for Wound Therapy Kits

LC Medical Concepts’ sterilization operations were not adequately validated to demonstrate sterility of its wound therapy kits, an Oct. 16-23, 2018, FDA inspection of the devicemaker’s Rochester, New York, facility revealed. Read More

Documentation Failures Plague Hyperbaric Technologies

Failure to document numerous activities including validation, corrective and preventive actions, process changes and others landed Hyperbaric Technologies a Form 483 following a Sept. 19-26, 2018, inspection of its Amsterdam, New York, manufacturing facility. Read More

Specification Developer Fails to Submit MDR Reports

Specification developer Circulatory Technology failed to submit medical device reports within 30 days of receiving complaints that its Better Bladder device failed during use, collapsing as a result of leaks, an Aug. 22 to Sept. 26, 2018 FDA inspection revealed. Read More

DoubleDay Cited for Failure to Control Nonconforming Products

DoubleDay Acquisitions failed to control products that didn’t meet specifications at its Moraine, Ohio manufacturing facility, the FDA discovered during a Dec. 10-14, 2018 inspection. Read More

Full Range Rehab Hit for Repeat Observations

Cincinnati, Ohio-based Full Range Rehab failed to file Medical Device Reports within 30 days of receiving information that one of its devices may have caused or contributed to a serious injury, according to a 483 issued to the firm following a Jan. 30-31 inspection. Read More

Valtronic Falls Short on CAPAs and Nonconforming Products

Contract device manufacturer Valtronic netted a Form 483 for inadequate CAPA procedures, nonconforming products and a failure to document validations at its Solon, Ohio plant. Read More

483 Roundup: Four Device Firms Cited for GMP, Other Failures

The FDA hit four facilities for various failures including inadequate validations, CAPAs, written procedures and supplier evaluations. Read More