Inspections and Audits

ARTICLES

Controls Found Lacking at Contract Manufacturer Thatcher

Contract manufacturer Thatcher Company failed to exercise appropriate controls over computers and related systems to assure that changes in production were only instituted by authorized personnel, FDA inspectors found during a Sept 10 to Sept. 18 inspection of the firm’s Salt Lake City, Utah, facility. Read More

Texas Neonatal Devicemaker Falls Short on Process Controls

FDA inspectors found shoddy process controls and a lack of validation documentation in a Sept. 17 to Sept. 21 inspection of Footprint Medical’s San Antonio, Texas facility. Read More

Nebraska Devicemaker Slammed for Design Project Documentation

The FDA cited devicemaker Streck for failing to document certain design elements for its Cyto-Chex blood collection tubes, serving the company a Form 483 after a September inspection of its La Vista, Nebraska facility. Read More

FDA Hits Microlight for Deficient Complaint Handling

The FDA flagged Microlight’s Sugar Land, Texas facility for its complaint handling procedures, in a Form 483 after conducting two inspections. Read More

FDA Boosts Foreign Device Inspections By 243 Percent

The FDA has increased its foreign device inspections by 243 percent since 2007, according to a new quality and enforcement report. Read More

Failure to Document OOS Results Lands Symmetry Medical 483

Failure to document OOS results and to find the root cause of defects landed surgical instrument and orthopedic implant manufacturer Symmetry Medical in hot water with the FDA following a Sept. 5 to Sept. 10 inspection of its Claypool, Indiana facility. Read More

Heartware Fails to Correct Earlier Warning Letter, 483 Observations

A May 17 to July 12 FDA inspection found that Miami Lakes, Florida-based devicemaker Heartware fell short on repeated quality system observations that were cited in a 2014 warning letter and a 2016 FDA Form 483. Read More

Quality System Failures Plague Texas-Based Ultrasonic Services

Numerous quality system failures were observed at Ultrasonic Services’ Houston, Texas facility during an Aug. 24 to Aug. 27 FDA inspection, after which the devicemaker landed a seven-item 483. Read More

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

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