FDA WARNING_LETTER - Animas Corporation - August 10, 2011

On December 27, 2011, the FDA issued a Warning Letter to Animas Corporation following an inspection from July 18 to August 10, 2011, which found their insulin infusion pumps to be misbranded. The firm failed to report serious injuries and deaths within 30 days, as required by 21 CFR 803.50(a)(1), citing examples of delayed reporting for diabetic ketoacidosis, high blood glucose requiring intervention, and coma/respiratory failure/hypoglycemia.

Animas also failed to develop, maintain, and implement adequate written Medical Device Reporting (MDR) procedures (21 CFR 803.17). Deficiencies included a lack of timely event identification, communication, and evaluation; an undefined "MDR Reportable Event"; no process for evaluating events outside the U.S.; no standardized review process for reporting criteria; unspecified personnel responsible for U.S. FDA reporting; and insufficient instructions for event investigation. The firm's August 26, 2011, response was deemed inadequate, as the submitted procedure did not establish required systems for MDR compliance.

Additionally, the inspection revealed quality system deficiencies under 21 CFR Part 820. Animas failed to identify actions needed to correct and prevent recurrence of nonconforming product (21 CFR 820.100(a)(3)), specifically regarding insulin