Inspections News

Device

OCCK Hit for Quality Management Failures

The FDA issued device manufacturer OCCK a Form 483 for issues with its Salina, Kansas facility’s quality system management and device history records. Read More
Device

IMDRF Mulls Device Single Review Program

The International Medical Device Regulators Forum is making progress in developing a medical device single review program (MDSRP). Read More
Drug

FDA Cites Florida OTC Drugmaker for Contamination Risks

The FDA flagged OTC drugmaker Laboratorios Quantium over conditions at its Medley, Florida facility. Read More
Drug

Gottlieb: FDA Will Increase Inspections of Stem Cell Facilities

The FDA will step up enforcement efforts against stem cell clinics in the coming months, Commissioner Scott Gottlieb told participants at the recent FDLI Enforcement, Litigation and Compliance Conference in Washington, D.C. Read More
Device

Alba Bioscience Rapped for MDRs

Alba Bioscience did not properly implement medical device reporting procedures or document control procedures, the FDA said following a September 2018 inspection. Read More
Device

Thermogram Cited for Complaint Handling

The FDA cited Thermogram Assessment Services for problems with its CAPA, complaint-handling and MDR procedures. Read More
Drug

Hundreds of FDA Staff to Be Remobilized for Inspection Activities

Following the FDA’s decision to expand its unpaid work to include inspection activities that are beyond “for-cause” inspections, Commissioner Scott Gottlieb announced on Tuesday that approximately 400 staff members will return to their posts, mostly for inspection-related tasks. Read More
Drug

FDA Cites GlaxoSmithKline for Problems With SOPs

The FDA cited GlaxoSmithKline’s East Durham, New York facility for failing to follow standard operating procedures. Read More
Device

Hemodialysis Solution Maker Dinged for Recurring Quality Issues

A 12-item 483 documents a litany of quality system failures the FDA found at Diasol East of Watertown, Tenn., during an Aug. 7 to Aug. 22 inspection. Read More
Device

FDA Scolds New Jersey Devicemaker for CAPA Handling

The FDA hit Monmouth Junction, New Jersey device manufacturer Replication Medical with a Form 483 following an inspection that revealed issues with the firm’s documentation of corrective and preventive action activities and device history records. Read More