ConvaTec Inc. – FDA Warning Letter, Feb 5, 2013

The FDA issued a Warning Letter to ConvaTec, Inc. following an inspection from January 8 to February 5, 2013, at their Skillman, New Jersey facility. The inspection revealed that their Flexi-Seal, Flexi-Seal Signal, and Flexi-Seal Signal (Upgrade) devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to provide required information under 21 U.S.C. § 360i and 21 CFR Part 803 (Medical Device Reporting - MDR).

Key violations include: 1. **Complaint Handling (21 CFR 820.198(a)(3)):** Failure to adequately evaluate all complaints, particularly those classified as "Product Issues," for MDR reportability. Examples cited include cases of device malfunction leading to patient exposure to fecal matter and leakage, where no medical adverse event decision was documented. ConvaTec's responses were deemed inadequate as they continued to categorize complaints rather than evaluate each for reportability. 2. **Design Change Control (21 CFR 820.30(i)):** Failure to establish and maintain adequate