Kawada Sanitary Products Co., Ltd. – FDA Warning Letter, Jul 31, 2014

On October 8, 2014, the FDA issued a Warning Letter to Kawada Sanitary Products Co., Ltd. following an inspection from July 28-31, 2014. The inspection revealed that the firm's bladder control and menstrual sanitary pads, classified as devices, were 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. **Process Validation (21 CFR 820.75(a)):** Failure to establish procedures and validate manufacturing/packaging lines. The firm's response, promising validation within six months, was inadequate as it didn't address procedure establishment, personnel training, or retrospective review. 2. **Complaint Files (21 CFR 820.198(a)):** Deficient complaint procedures lacking MDR reportability criteria and evaluation of complaints from other countries for similar products. Specific complaints were not evaluated for MDR reportability. The firm's revised procedure was inadequate, still