A Medical Device Daily

Insulin pump manufacturer Animas (West Chester, Pennsylvania) reported that it received a warning letter last week from the Philadelphia District Office of the FDA.

The letter, dated Feb. 24, 2005, was issued after the inspection of Animas' West Chester facility in the fall of 2004. the company said the letter concerns procedures and implementation of corrective and preventative action under Current Good Manufacturing Practices (CGMP) requirements, as well as the acquisition and reporting of information required under the Medical Device Reporting (MDR) regulation.

In reporting the letter, Animas said it is "committed to working cooperatively with the FDA to resolve the matters in the FDA letter."