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

Source: https://www.keypedia.com/records/warning_letter/transdermal-cap-inc/f58e0eee-ad95-4dae-bcf6-07941c49ac70

> FDA WARNING_LETTER for Transdermal Cap Inc. on June 30, 2015. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Transdermal Cap Inc.
- Inspection Date: 2015-06-30
- Product Type: Devices
- Office Name: Cincinnati District Office
- Summary: 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

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## Related Officers

- [Director](https://www.keypedia.com/people/toniette-k-williams/5535cf2e-989e-4f80-88ff-1bd925980ef4)

Company: https://www.keypedia.com/companies/transdermal-cap-inc/04de6863-f166-4f39-af50-2e3af20c851d

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22