Church & Dwight Inc – FDA Warning Letter, Feb 17, 2011

On January 25, 2011, through February 17, 2011, the FDA inspected Church & Dwight Co., Inc. in Princeton, New Jersey, which manufactures condoms, powered toothbrushes, ovulation test kits, and pregnancy tests. The inspection revealed that the firm's powered toothbrushes and condoms are misbranded under section 502(t)(2) of the Act because the firm failed to furnish material or information required by section 519 of the Act and 21 CFR Part 803 Medical Device Reporting (MDR) regulation.

Violations include: 1. Failure to submit MDR reports within 30 calendar days for deaths or serious injuries (21 CFR 803.50(a)(1)). Examples include a chipped tooth from a Spinbrush and urinary tract infection/contact dermatitis from condoms. The firm's responses indicated a retrospective review and planned reporting by March 31, 2011, which appeared adequate for this specific violation. 2. Failure to submit MDR reports within 30 calendar days for malfunctions likely to cause death or serious injury if recurred (21 CFR 803.50(a)(2)). An example is a Spinbrush malfunction leading to injury, which was reported as "Other" instead of "Malfunction," despite meeting the definition of a reportable malfunction. The firm's responses were deemed inadequate.