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# No FDA OK in Effect for Induction Therapies’ Product
- URL: https://www.fdaweb.com/no-fda-ok-in-effect-for-induction-therapies-product/
- Published: 2021-12-07T12:00:00.000Z
- Updated: 2026-09-14T17:24:46.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150714

FDA says a 6/15-6/29 inspection at the Induction Therapies medical device operation in Louisville, KY, determined that the firm manufactures Collagen P.I.N., a microneedling product. An 11/23 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/induction-therapies-llc-616487-11232021?ref=fdaweb.com) says the device is offered for sale and distributed in the U.S. without marketing approval, clearance, or authorization from FDA.

The letter says the product is adulterated because the company does not have an approved PMA or IDE in effect and did not notify the agency of its intent to introduce the device into commercial distribution.

Induction Therapies was told to take prompt action to correct the violations and to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with documentation of each of the steps and a timetable for completing the corrections.