During a March 12 inspection at CGR Products MN, LLC. in Inver Grove Heights, the Food and Drug Administration (FDA) issued three citations for device compliance, according to information posted on the FDA’s website.
Details from the FDA site show the company was cited for the following issues:
- ‘Production controls do not include implementation of monitoring and measurement of process parameters and product characteristics.’
- ‘Records of the nature of nonconforming product and any subsequent action taken, including the evaluation, and any investigation and the rationale for decisions, were not adequately maintained.’
- ‘Corrective action procedures defining the requirements for reviewing the effectiveness of corrective action taken have not been adequately documented.’
The FDA conducts routine inspections at facilities nationwide to assess compliance with laws and regulations established to promote public health. Findings from these inspections are published openly.
The FDA states on its website the agency has primary responsibility for overseeing the safety and quality of human and animal drugs, biological products, medical materials, and tobacco products.
Details in this story are drawn from the U.S. Food and Drug Administration. The underlying data is available here.
