Inspections News

Device

Validation Issues Uncovered at Dannoritzer Medizintechnik

Germany’s Dannoritzer Medizintechnik received a six-item Form 483 following a Feb. 5 to Feb. 8 inspection of its Baden-Wuttemberg facility for inadequate validation and process control procedures for its surgical equipment. Read More
Device

Risk Analysis Missing at Chinese Medical Laser Maker

Risk analysis, validation procedures and appropriate test methods were found to be inadequate at China’s Beijing ADSS Development during a Feb. 5 to Feb 8 FDA inspection of the firm’s Beijing facility. Read More
Drug

FDA Raps Hospira for Repeat Violations at Kansas Plant

The FDA slammed Hospira’s sterile drug facility in McPherson, Kansas, after finding the same violations during recent inspections that were flagged during earlier probes. Read More
Drug

FDA Warns Texas Compounder for Adulterated Drugs

Serious deficiencies in sterile drug production at Greenpark Compounding in Houston, Texas, may put patients at risk, the FDA said in a warning letter to the compounder. Read More
Device

FDA Warns US Vascular on Complaints, MDRs

The FDA issued a warning letter to US Vascular for failing to correct deficiencies in its complaint reviews and to fix problems with medical device reporting, among other violations. Read More
Device

China’s Copious International Stumbles on MDRs, Complaints

China’s Copious International fell short on submitting medical device reports and tracking complaints, as well as validation procedures, a Feb. 5 to Feb. 8 inspection of the firm’s Guang Dong, China facility revealed. Read More
Drug

FDA Moves to Modernize Inspections for Sterile Injectables

The FDA is streamlining its reporting of inspections for sterile injectable drugs to help make risk-based regulatory decisions, Commissioner Scott Gottlieb announced Friday. Read More
Drug

Texas Drugmaker Called Out for Quality Issues

The FDA cited OTC drugmaker Quest Specialty of Brenham, Texas, for lacking written quality procedures during a July 31-August 3 inspection. Read More
Device

FDA Hands Vector R&D a 483

Failure to establish adequate procedures for receiving, reviewing and evaluating complaints landed devicemaker Vector Research and Development in hot water with the FDA during a July 5 to July 8 inspection of its University Place, Washington plant. Read More
Device

Risk Analysis Lacking, FDA Tells Innovative Medical Equipment

Failure to conduct adequate risk analysis for its Thermazone heating and cooling device landed Innovative Medical Equipment a Form 483 following a July 10 to July 17 FDA inspection of its Lyndhurst, Ohio facility. Read More