hapabapa
The U.S. Food and Drug Administration (FDA) has warned the medical distributor Cardinal Health (NYSE:CAH) for marketing unauthorized syringes, according to a safety update from the regulator on Thursday.
The warning issued on Wednesday followed an inspection at one of its manufacturing plants in Illinois late last year.
During the inspection, the agency has found that Cardinal Health (CAH) was marketing unapproved devices made of certain piston syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd., a China-based manufacturer of plastic syringes.
The issues also extended to the internal controls that CAH has established to ensure that its products and services meet the required standards.
“Your firm should take prompt action to address any violations identified in this letter,” the FDA wrote, noting that failure to do so will lead to regulatory actions, including penalties.
The letter followed a warning the FDA issued to Jiangsu Shenli in March for violations related to the sale and distribution of unauthorized plastic syringes made in China.
More on Cardinal Health
- Cardinal Health: Solid Business But Overvalued
- Cardinal Health, Inc. (CAH) Presents at Barclays 26th Annual Global Healthcare Conference (Transcript)
- Cardinal Health: Continued Business Growth And Huge Medical Supplies Market Penetration
- Cardinal Health stock dips after ending OptumRx contract
- Biggest stock movers today: MTTR, CAH, INFA, crypto-related stocks and more