CareFusion Shutters NJ Plant; Gets FDA Warning Letter

CareFusion Corporation, headquartered in San Diego, Calif., is shuttering its Totowa, N.J. plant  and laying off 390 employees as the work performed there is being moved to Mexico. The closing will be implemented in stages over the next year and a half.

CareFusion took over the Totawa plant from GE Healthcare when it acquired that company’s Vital Signs division in November last year for $500 million.

“When we evaluated our manufacturing footprint, we have manufacturing facilities around the country and the world… we made the decision to consolidate those types of jobs in our Mexicali facility,” said company spokesman Troy Kirkpatrick.

The decision, according to Kirkpatrick, was based in part on the lower cost of manufacturing in Mexico, as well as the established presence of manufacturing expertise and high quality production.

The Totowa factory makes disposable respiratory products such as masks and hoses. Some non-manufacturing jobs also located in Totowa, such as finance and human resources, will be moved to existing CareFusion offices in San Diego and Vernon Hills, Ill.

The company’s Vernon Hill location was also the recipient of a warning letter from the U.S. Food and Drug Administration (FDA) last month. In an investigation conducted between September and November of last year, the regulatory agency found that the facility was not practicing current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) Regulation found in CFR (Code of Federal Regulations) Title 21. CareFusion Vernon Hill location makes makes class I and class II neonatal and adult breathing circuits for respirators, adult oxygen masks, Chloraprep skin preparation products, diagnostic procedure trays, soft tissue and bone biopsy needles, reusable surgical instruments and sterilization containers, among other products. Violations included misbranding, inadequate medical device reporting, and a failure to adequately address issues raised last year by the FDA.

CareFusion has 15,000 employees in 20 countries worldwide with sales of $3.55 billion. The company made MPO’s Top 30 Companies list this year.