FDA WARNING_LETTER - Transdermal Cap Inc. - June 30, 2015

On June 11-30, 2015, an FDA inspection of Transdermal Cap Inc. in Cleveland, OH, revealed that their LaserCap device, intended for hair growth, is adulterated under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Violations include: 1. **Complaint Handling (21 CFR 820.198(a)):** Failure to implement procedures, with 125 complaints informally documented, lacking required forms, closure dates, MDR evaluations (despite three involving patient reactions), investigation decisions, and investigations for device failures. 2. **Corrective and Preventive Actions (CAPA) (21 CFR 820.100(a)):** Failure to adequately implement procedures, including not analyzing data sources for nonconforming product, undocumented corrective actions for wire fraying, and unverified/unvalidated CAPA for cable pull-out. 3. **Control of Nonconforming Product (21 CFR 820.90(a)):** Failure to implement procedures, with 71 nonconforming laser boards lacking proper documentation (evaluation, investigation, disposition, review). 4. **Design Verification (21 CFR 820