SPINE DEVICE FIRM HIT WITH WARNING LETTER
The FDA issued a warning letter Aug. 31 to a chiropractic device manufacturer for current good manufacturing practice (cGMP) violations, including a failure to specify product design features and identify possible product risks.
The letter was issued to Frye Health Systems, which manufactures a spine-adjustment device called the Frye Adjusting Instrument. The letter was posted to the FDA website Sept. 12.
Based on an inspection conducted July 17 through 19, the FDA found the firm's devices to be adulterated because they did not conform to cGMP requirements.
"Your firm failed to identify, approve and document appropriate design inputs prior to the start of its formal design of the Frye Adjusting Instrument," the letter said. Specifically, the firm presented a one-page, undated document in which it referenced multiple terms of design inputs without documenting specific physical and performance device requirements.
The firm also failed to identify all possible risks associated with the device and to document the results of its risk analysis, the letter said. The firm did not define the maximum force output and design features or refer to specific, recognized standards to prevent the device's force output from exceeding the firm's approved maximum specification. The firm claimed to have measured the force output but did not document the results, and also did not describe and document other risk controls such as warnings and user instructions or training, the letter said.