InBios International’s facility in Seattle, Wash., drew a Form 483 from the FDA for not following its standard operating procedures (SOP) for several activities. Read More

Inadequate device history records (DHRs) and other deficiencies landed Xintec, also known as Convergent Laser Technologies, a Form 483 after an inspection of its Alameda, Calif., facility. Read More

CAREstream Medical drew an FDA Form 483 citing various failures in documentation following an agency inspection of the company’s Maitland, Fla., facility from April 25-27. Read More

Alexandria, Va.-based Spok received a Form 483 after an April inspection by the FDA found incomplete corrective and preventive action (CAPA) procedures and design control lapses. Read More

LV Liberty Vision lacked proper design validation and verification testing, the FDA said in a Form 483 issued following an inspection of the ophthalmology devicemaker’s Portsmouth, N.H., facility. Read More

CellEra has received a Form 483 for not having proper procedures for handling complaints and corrective actions and for other deficiencies observed during an April 11-14 inspection of the company’s Monroe, Ohio, facility. Read More

Aggredyne drew a Form 483 from the FDA for deficient design change validations and other lapses following an inspection of its Houston, Texas, manufacturing facility from March 29 to April 14. Read More

Devon Orthopaedic Implants received a Form 483 from the FDA following a May inspection of its facility in King of Prussia, Pa., for failing to fully investigate complaints or report possible medical device issues. Read More

The FDA issued Revolutionary Science a Form 483 for documentation issues involving design changes, nonconforming product and in-process testing observed during an inspection of its Shafer, Minn., facility in April. Read More

The FDA handed Elite-Medical a Form 483 for problems with control of nonconforming products and a supplier issue observed during an inspection of its Florence, Ala., facility in April. Read More

An FDA inspection of Med Pen Concepts’ facility in Woburn, Mass., found the company lacked documentation of corrective and preventive action (CAPA) procedures, device history records, risk assessments and audit reviews for its plasma pen devices. Read More