The Food and Drug Administration (FDA) issued six citations to The Side Lyer Company, LLC in Orlando during an inspection conducted on March 12, as shown in data available on the FDA’s website.
The scope of the inspection included:
- Compliance: Devices
- Postmarket Assurance: Devices
FDA records indicate the company received citations for the following:
- ‘Records needed to demonstrate compliance with applicable regulatory requirements have not been established and maintained.’
- ‘Records to provide evidence of conformity to requirements and the effective operation of the quality management system have not been maintained.’
- ‘The necessary competence for personnel performing work that affects product quality has not been determined.’
- ‘Records of risk management activities in product realization were not adequately maintained.’
- ‘Design and development changes were not reviewed, verified, validated, and approved before implementation.’
- ‘Procedures to ensure that purchased product conforms to specified purchasing information have not been documented.’
The FDA regularly inspects facilities nationwide to assess whether workplaces and their products meet laws and regulations intended to protect public health. Inspection outcomes are made publicly available.
According to the agency, the FDA is responsible for overseeing the safety and quality 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.
