The Food and Drug Administration (FDA) cited Collaborative Care Diagnostics, LLC. in Eagan for four violations during a Feb. 9 inspection, according to data posted on the FDA’s website.
The inspection addressed the following areas:
- Compliance: Devices
- Postmarket Assurance: Devices
FDA records show the company received citations for:
- ‘The medical device(s) label did not have a unique device identifier (UDI) present in easily readable plain-text and automatic identification and data capture (AIDC) technology.’
- ‘The information required by the Global Unique Device Identification Database for each medical device version or model required to bear a unique device identifier (UDI) was not provided.’
- ‘One or more processes for risk management in product realization have not been adequately documented.’
- ‘Review of design and development changes did not include evaluation of the effect of the changes on constituent parts and product in process or already delivered, inputs or outputs of risk management and product realization processes.’
The FDA regularly inspects facilities nationwide to determine whether workplaces and their products comply with FDA-regulated laws and regulations designed to protect public health. Inspection results are made publicly available.
The FDA’s website describes the agency’s primary duties as monitoring the safety and quality of the production and distribution of human and animal drugs, biological products, medical supplies, and tobacco products.
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
