The FDA found design verification and quality audit deviations in a February/March inspection OptumHealth Care Solutions facility in Rye Brook, New York.
Investigators found the firm had no procedure in place requiring the company to review the results of its contract firm’s verification activities. The contract firm also had no documentation demonstrating it had reviewed the design verification it provided.
The firm’s procedures for design revisions also did not define what is considered a “major” or “minor” change, according to the 483, relying instead on a contract firm’s definition, which the agency deemed inadequate. Investigators also found the design input for the Optum TeleHealth Application software did not include proper documentation of reviews and approval for changes.
The firm’s complaint-handling procedures did not accurately specify responsibility for certain complaint-handling and complaint determination functions, and did not state job titles. Similarly, its quality audit procedure did not specify the frequency of audits.
Lastly, OptumHealth failed to properly define certain job titles or individuals for certain functions within the company’s management review procedure, the agency said.
Read the full 483 here: www.fdanews.com/08-02-18-optumhealthcaresolutionsinc483.pdf. — Zack Budryk