On Feb. 13, Automated Ophthalmics, Inc. in Elkridge was issued five violations by the Food and Drug Administration (FDA) during an inspection, the agency’s records show.
The inspection focused on these areas:
- Compliance: Devices
- Postmarket Assurance: Devices
According to the FDA website, the following citations were given:
- ‘The medical device(s) label did not have a unique device identifier (UDI) present in.’
- ‘Records of complaint investigations do not include.’
- ‘Product was not protected from alteration, contamination, or damage during processing, storage, handling, and distribution by.’
- ‘Complaint handling records were not adequately maintained.’
- ‘Nonconforming product was not adequately evaluated to determine the need for an investigation and notification of any external party responsible for the nonconformity.’
The FDA conducts regular inspections across the United States to check if workplaces and their products follow all relevant laws and regulations supporting public health. They make these results publicly accessible.
The FDA’s website notes the government agency oversees the safety and quality of human and animal drugs, biological products, medical devices, and tobacco products through regulation of their manufacturing and distribution.
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.