Devicemaker CooperSurgical, a division of CooperCompanies, was slapped with a five-observation Form 483 for manufacturing problems primarily focused on its intrauterine device (IUD) Paragard T380A copper contraceptive. Read More

Irwindale, Calif.-based W.H.P.M has received a warning letter from the FDA for distributing unapproved COVID-19 tests in the U.S. Read More

Texas Medical Technology received a Form 483 from the FDA for a variety of lapses observed during a Feb. 16 to March 3 inspection at its Houston facility, ranging from inadequate device records to ineffective medical device reporting (MDR) procedures. Read More

C&A Tool’s Auburn, Ind. device manufacturing facility received a Form 483 from the FDA for good manufacturing practice issues and other deficiencies observed during a Feb. 28 to March 3 inspection. Read More

Seno Medical Instruments received a Form 483 after the FDA inspected its San Antonio, Texas, facility last February and March, listing inadequate design control procedures and other lapses. Read More

Medical Device Single Audit Program (MDSAP) regulatory authorities (RAs) have extended the program’s remote audit arrangements until Sept. 30. Read More

Wound Care Technologies, a provider of wound therapy systems, received a Form 483 from the FDA for inadequate inspection procedures for incoming products, as well as for its handling of complaints and medical device reporting (MDR). Read More

The FDA hit Heany Industries, a manufacturer of industrial ceramics and thermally based coatings, with a Form 483 for inadequate validations and corrective and preventive action (CAPA) procedures after an inspection of its Scottsville, N.Y., facility in March. Read More

Angel Medical Systems, a device company that offers an implantable cardiac monitoring and alerting system, was hit with a Form 483 for corrective and preventive action (CAPA) and documentation lapses observed during a March inspection of its Eatontown, N.J., facility. Read More

The FDA issued Photonic Health an eight-observation Form 483 after an inspection of the company’s Ocala, Fla., facility in March found the firm had failed to address deficiencies observed in a previous inspection. Read More

The FDA issued Stand Aid of Iowa a Form 483 that listed several deficiencies seen in previous inspections, including inadequate procedures for nonconforming products and for assigning serial numbers to finished devices. Read More

The FDA issued American Contract Systems a Form 483 that listed several deficiencies seen in previous inspections, including lax validations and “ineffective” corrective and preventive actions (CAPA). Read More