Vision Chips, Inc. in Laguna Niguel was issued a single citation by the Food and Drug Administration (FDA) following a Feb. 27 inspection, according to information published on the FDA’s website.
The inspection evaluated these aspects:
- Compliance: Devices
- Postmarket Assurance: Devices
FDA records reveal the company was cited for the following issue: ‘The labels of the medical device(s) do not bear a unique device identifier (UDI) that meet the requirements of 801 Subpart B and 21 CFR 830.’
The FDA regularly inspects facilities nationwide to verify if workplaces and their products follow FDA-regulated laws and rules intended to protect public health. Outcomes of these inspections are shared publicly.
As described on its website, the FDA is a government entity overseeing the safety and quality of human and animal drugs, biological goods, medical supplies and tobacco products.
Details for this report came from the U.S. Food and Drug Administration. Source documentation is available here.
