The Food and Drug Administration (FDA) gave Unik Orthopedics, Inc. in San Jose seven citations following a March 13 inspection, according to data posted on the FDA’s website.
The inspection reviewed the following areas:
- Compliance: Devices
- Postmarket Assurance: Devices
Citations listed for the company on the FDA website include:
- ‘Top management did not adequately review the quality management system at documented planned intervals to ensure its continued suitability, adequacy, and effectiveness.’
- ‘One or more processes for risk management in product realization have not been adequately documented.’
- ‘Procedures to ensure that purchased product conforms to specified purchasing information have not been adequately documented.’
- ‘Procedures for product identification throughout product realization were not adequately documented.’
- ‘Justification for not investigating a complaint(s) was not adequately documented.’
- ‘Internal audits have not been adequately conducted at planned intervals to determine whether the QMS is effectively implemented and maintained.’
- ‘Corrective action procedures defining the requirements for reviewing the effectiveness of corrective action taken have not been adequately documented.’
The FDA regularly inspects facilities nationwide to verify that workplaces and products meet FDA laws and related health standards. The outcomes of these inspections are made available to the public.
As described on its website, the FDA is a federal agency responsible for overseeing the safety and quality of drugs, biological products, medical supplies and tobacco products for both humans and animals.
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
