Federal regulators warn Johnson & Johnson’s insulin pump business to correct violations
January 12th, 2012 // 1:33 pm @ jmpickett
Federal drug regulators have chastised Johnson & Johnson’s subsidiary, Animas, for selling faulty insulin pumps and failing to report injuries suffered by patients using its devices.
In a warning letter to Animas managment, regulators with the Food and Drug Administration described numerous instances when the company failed to comply with regulations requiring it to report events involving its devices. In two cases, Animas waited months to notify regulators of events that required patients using the company’s devices to be hospitalized, according to the letter.
The letter, which was posted on the FDA’s website Tuesday, also noted the company’s failure to maintain procedures for communicating events to regulators as well as its failure to properly inform the agency after problems were reported with the One Touch Ping insulin pump device and the 2020 insulin pumps.
The Dec. 27 warning letter echoes of quality control issues that have hounded Johnson & Johnson for nearly two years and tarnished many of its top-selling brands of over-the-counter medicines.
While the New Brunswick-based healthcare giant has resumed shipping supplies of its product, the manufacturing plant at the center of the massive recall remains closed. New product is being shipped from other manufacturing sites. Johnson & Johnson CEO William Weldon has said repeatedly that quality control procedures are being reviewed throughout the company.
“I think the FDA, now that it has its eyes on J&J, is taking a look at everything,’’ said Les Funtleyder, a pharmaceutical industry analyst with Miller Tabak. “There’s no question, the FDA is getting more stringent.’’
“The specific violations noted in this letter and the observations issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems,’’ the FDA said in its five-page letter.
Animas spokeswoman Caroline Pavis said in a statement that the warning letter is based on a multi-day inspection of the company’s facility in West Chester, Pa. The inspection occurred between July 18 and Aug. 10.
The company initially responded to the FDA’s concerns Aug. 26 when the agency requested more documents related to device-maker’s internal quality systems processes and the design enhancements Animas made to improve problems with its insulin pump keyboards.
Animas, which was acquired by Johnson & Johnson in 2006, has 15 business days to detail the steps it will take to correct the violations, according to the letter. If the violations are not corrected, the company could face a variety of penalties, including fines and injunctions.
“We are dedicated to quickly resolving the FDA’s outstanding concerns,’’ Pavis said in an emailed statement.
