FDA WARNING_LETTER - National Creative Enterprises, Inc. - March 03, 2011

The FDA issued a Warning Letter to National Creative Enterprises, Inc. following an inspection from December 15, 2010, to March 3, 2011. The inspection revealed that the firm's medical device replacement batteries 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) and § 352(o).

Key violations include: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: No written procedures for analyzing, investigating, and correcting quality problems, as evidenced by unaddressed RMA issues (e.g., incorrect connectors). 2. **Failure to establish and maintain complaint handling procedures (21 CFR 820.198(a))**: Lack of written procedures for receiving, reviewing, and evaluating complaints, including unique identification codes, investigations, and MDR reportability assessments. 3. **Failure to investigate complaints (21 CFR 820.198(c))**: 21 of 29 RMAs lacked documented investigations, including dates, results, product IDs, or corrective actions for issues like batteries overheating or failing