Inspections News

Drug

Texas Firm Hit for Cleaning, Product Reviews

Fort Worth drugmaker CBI Laboratories was slapped with a Form 483 for multiple violations at its facility including a flawed quality unit, the lack of annual product reviews and a failure to conduct cleaning validations. Read More
Drug

South Korean OTC Maker Slammed for Multiple Issues

The FDA issued a warning letter to a South Korean OTC manufacturer Dermameal for violations at its facility in Gyeonggi-do, including the incomplete quality testing and an inadequate stability program. Read More
Device

FDA Calls Out Florida Contract Manufacturer for Complaint Handling

The complaint procedure had no requirements for investigating complaints without a lot number. Read More
Device

California Devicemaker Slammed for Labeling Activities, Validation

The firm didn’t put in place written procedures for labeling of its FemCap devices. Read More
Drug

Spanish Sterile Drugmaker Cited for Quality Lapses

The FDA hit Laboratorio Reig Jofre for numerous violations at its Barcelona sterile drug manufacturing facility, including inadequate smoke studies and failing to qualify contract service providers. Read More
Drug

FDA’s Top Ten GMP Inspection Findings for FY 2019

With less than two weeks to go in fiscal 2019, an FDAnews analysis of the FDA’s GMP inspection reports for the year shows that drugmakers continue to stumble at the same old hurdles. Read More
Device

Lusys Laboratories Slammed for Host of Violations in 483

Design control procedures didn’t include instructions for design validations. Read More
Device

FDA Issues Warning to Indiana Devicemaker

The FDA issued a warning letter to Polymer Technology Systems — doing business as PTS Diagnostics — arising from an inspection earlier this year of its facility in Indianapolis. Read More
Drug

San Diego Manufacturer Cited for Shoddy Equipment Design

An FDA inspection of Ajinomoto Althea’s San Diego, California sterile drug facility found serious problems with its equipment setup, including a filling machine conveyor belt that caused vials to fall off the belt. Read More
Device

Infections from Implanted Devices Earn Stimwave a 483

FDA investigators found Stimwave Technologies’ complaint handling procedures and corrective and preventive actions for its implantable pain treatment devices were not up to par, during a Jan. 29-Feb. 15 inspection of the firm’s Pompano Beach, Fla. Facility. Read More