FDA Issues Second Quality Warning to Medline
The FDA issued a warning letter to Medline for failing to investigate microbial contamination and maintaining inadequate cleaning practices. This marks the second such action in two months and requires the company to provide a risk assessment and remediation plan within 15 days.
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The United States Food and Drug Administration (FDA) issued a second warning letter to Medline in two months over manufacturing quality violations. The May 28 letter follows an April warning regarding syringe defects and flags failures to investigate microbial contamination in finished drug products. The regulator warned that repeated failures at multiple sites demonstrate inadequate management oversight and could result in regulatory or legal action.
