The Food and Drug Administration (FDA) issued six citations to The Side Lyer Company, LLC in Orlando following an inspection conducted on March 12, as shown in data on the FDA’s website.
Inspectors reviewed the following operational areas at the facility:
- Compliance: Devices
- Postmarket Assurance: Devices
As noted on the FDA website, the company was cited for these concerns:
- ‘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 carries out routine inspections of facilities nationwide to evaluate workplaces and their products for compliance with relevant FDA laws and regulations aimed at protecting public health. Information about these inspections is made available to the public.
The FDA website explains that the agency’s main responsibilities include overseeing the safety and quality of human and animal drugs, biological products, medical devices and tobacco products.
Details in this report were sourced from the U.S. Food and Drug Administration. Full data is accessible here.
