FDA WARNING_LETTER - Abbott Diabetes Care, Inc. - March 05, 2010

On July 2, 2010, the FDA issued a Warning Letter to Ms. Heather L. Mason, President of a firm in Alameda, California, following an inspection from February 8 to March 5, 2010. The inspection revealed that the firm's FreeStyle glucose monitoring and Navigator continuous monitoring systems, classified as devices under section 201(h) of the Act, were adulterated. The manufacturing, packing, storage, or installation methods and controls did not conform to the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

The letter detailed several violations: 1. **Failure to adequately validate processes (21 CFR 820.75(a)):** Specific quality control testing and inspection for certain lots (e.g., 0804427, 0804521, 0804624, 0811405, 0811433) were not performed as required by established procedures. The firm's response was deemed inadequate as the investigation was incomplete. 2. **Failure to verify or validate corrective and preventative actions (21 CFR 820.100(a)(4)):** Exception Reports (ERs) for issues like empty blister packs (ER (b)(4)) and