San Antonio, Texas-based ErgoMed received a Form 483 after an FDA inspection found a lack of supplier and product controls as well as repeated quality lapses.

Bethesda, Md.-based RightEye, manufacturer of the RightEye Vision System, has received a warning letter from the FDA for marketing its device without a premarket approval application for new indications, failure to maintain written design control procedures and other serious lapses.

Light Age received a Form 483 for multiple deficiencies observed in an inspection of its Somerset, N.J., facility including the lack of a device master record and failing to launch corrective and preventive action (CAPA) procedures.

The SEIU-United Healthcare Workers West union in California has petitioned the FDA to issue corrective recalls for Fresenius 2008K2, 2008T, and 2008T BlueStar hemodialysis machines to protect patients from high ultrafiltration rates and assure accurate conductivity — concentration of dialysis fluid.

Ceragroup Industries (CGI), a Florida manufacturer and distributer of dental porcelain products, recently received a Form 483 citing repeat problems with incomplete corrective and preventive action (CAPA) procedures and equipment lacking proper calibration. 

Failure to fully investigate complaints or to properly qualify suppliers landed devicemaker Austco Marketing and Service a Form 483 after an FDA inspection at its Irving, Texas, facility.

An FDA inspection of an iRhythm Technologies facility in Irvine, Calif., resulted in a Form 483 to the firm for not establishing corrective and preventative actions, not submitting a medical device report (MDR), and other issues regarding the company’s cardiac monitoring system.

The FDA has issued separate warning letters to Olympus Medical Systems and its subsidiary Aizu Olympus for failure to report malfunctions of endoscopes and inadequate validations.

An FDA inspection of East Troy, Wis., implantable medical device manufacturer Cytophil showed unvalidated processes and inadequate testing, among other lapses.

Buffalo, N.Y.-based Pedia Parents was handed a Form 483 after a July inspection found the company lacked adequate procedures for supplier monitoring, design verifications and medical device reports (MDR), among other lapses.

The FDA sent a Warning Letter to RoyalVibe Health for unapproved ultrasound technology devices the company has not removed from the market and for continuing to market the products online.