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# Multiple Pinnacle BioLabs Violations Seen
- URL: https://www.fdaweb.com/multiple-pinnacle-biolabs-violations-seen/
- Published: 2024-04-30T12:00:00.000Z
- Updated: 2026-09-14T14:29:41.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156875

An FDA 10/27-11/3/2023 inspection at Pinnacle Labs of Tennessee, doing business as Pinnacle BioLabs in Nashville, TN, identified multiple violations in the firm’s marketing and distribution of the Second Generation FIT Fecal Immunochemical Test. A just-released 4/17 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pinnacle-labs-tennessee-llc-dba-pinnacle-biolabs-676367-04172024?ref=fdaweb.com) says the company is marketing and distributing a previously cleared test for a new use (colorectal cancer screening) that is different from the cleared use (detection of occult blood).

“FDA is not aware of any data demonstrating the safety and effectiveness of your device when intended for use in colorectal cancer screening,” the letter says. “If you have data demonstrating these performance characteristics, please provide that information to the agency in a new premarket submission.”

The letter says the device is adulterated because Pinnacle does not have an approved application for premarket approval or an IDE for it. It also is misbranded, FDA says, because the company did not notify the agency of its intent to introduce the device into commercial distribution.

The inspection revealed these Quality System Regulation violations:

- failing to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
- failing to establish procedures for implementing corrective and preventive action; and
- failing to establish and maintain adequate design control procedures to control the design of the device to ensure that specified requirements are met.

The inspection also found that Pinnacle failed or refused to furnish material or information about the device required under Medical Device Reporting regulations.

The company was told to take prompt action to correct the violations and prevent their recurrence. It is to respond with a list of specific actions it has taken, with documentation of each action, and a schedule for completing the corrections.