# FDA WARNING_LETTER - SmartPractice Denmark ApS - Unknown Date

Source: https://www.globalkeysolutions.net/records/warning_letter/smartpractice-denmark-aps/9356c4f5-5aeb-4e64-b193-dfc9a199b7c6

> FDA WARNING_LETTER for SmartPractice Denmark ApS on Unknown Date. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: SmartPractice Denmark ApS
- Product Type: Biologics
- Office Name: Center for Biologics Evaluation and Research
- Summary: On May 3, 2013, the FDA's Center for Biologics Evaluation and Research (CBER) issued a Warning Letter to SmartPractice Denmark AS regarding promotional materials for T.R.U.E. TEST, an epicutaneous patch test for allergic contact dermatitis. The FDA reviewed materials submitted on January 17, 2013, in response to a November 29, 2012, information request.

The letter identified several violations:
1.  **False or Misleading Promotional Materials/Omission of Risk Information:** Most promotional materials (excluding the final reference manual 78314 and sales aid 78199-A) were deemed false or misleading because they omitted crucial risk information, including contraindications (e.g., severe allergic reactions, injured skin) and warnings/precautions (e.g., acute allergic reactions, sensitization, extreme positive reactions, excited skin syndrome, tape reactions, irritant contact dermatitis), and common adverse reactions (e.g., burning, tape irritation, persistent reactions, erythema, hyper/hypo pigmentation). This misbrands T.R.U.E. TEST under Sections 502(a) and 201(n) of the Federal Food, Drug, and Cosmetic Act (the Act).
2.  **Lack of Adequate Directions for Use:** All referenced promotional materials appeared to be disseminated without the FDA-

## Related Officers

- [Director -  - Ex-FDA](https://www.globalkeysolutions.net/people/mary-a-malarkey/11b99e21-5f75-4b61-83bc-d140e35e4dae)

Company: https://www.globalkeysolutions.net/companies/smartpractice-denmark-aps/e2173ee1-5bc6-4adb-af29-e5c541994c7e

Office: https://www.globalkeysolutions.net/offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d