Compliance Management

FDA Cites Three Pharma, Five Medical Device Companies

Feb 01, 2017

RAPS

The U.S. FDA distributed warning letters for three pharmaceutical manufacturers and five medical device companies located in India, China, Canada, Korea, Germany and Italy, according to the Regulatory Affairs Professionals Society (RAPS).

The pharma companies included Milan, Italy-based Facta Farmaceutici, after an inspection uncovered original data showing failed results for multiple sterile drug products, but data the company reported showed passing results, the story said.

For a second company, Gujarat, India-based CTX Life Sciences, FDA investigators “observed rust, insects, damaged interiors, and/or drug residues” in pieces of manufacturing equipment.

The third company, Cixi City, China-based Ningbo Zhixin Bird Clean-Care Product Company’s Quality Control Unit (QCU) failed to review and approve drug product production and control records.

On the medical device side, FDA also sent warning letters to Korea-based Shina Corp., Canada’s Savaria Concord Lifts, Korean-based Incyto, Montreal-based Ropack and Berlin-based Biotronik.

Read the full RAPS story