During a Feb. 6 inspection, CAREstream Medical, Ltd. in Lake Mary was issued seven violations by the Food and Drug Administration (FDA), FDA data shows.
The inspection reviewed compliance and postmarket assurance for the company’s devices.
- Compliance: Devices
- Postmarket Assurance: Devices
The FDA reported that the following violations were found at the facility:
- ‘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 quality management system was not documented in accordance with applicable regulatory requirements.’
- ‘Top management did not ensure that applicable regulatory requirements were determined and met.’
- ‘Design and development procedures were not documented.’
- ‘Records of the results of evaluation and selection of supplier capability or performance were not maintained.’
- ‘Software used in production and service provision was not validated prior to initial use and after changes to such software or its application.’
- ‘Procedures for timely complaint handling have not been adequately documented.’
The FDA conducts regular inspections at facilities nationwide to verify compliance with federal laws and regulations designed to protect public health. Results from these inspections are made available to the public.
The FDA’s website states the agency’s main responsibility is the oversight of production and distribution of drugs, biological products, medical devices and tobacco for both safety and quality.
The information for this article comes from the U.S. Food and Drug Administration. The original data can be accessed here.
