June 3 (Reuters) – The U.S. FDA issued a warning letter to medical device maker Medline over violations of manufacturing quality standards, the second such action against the company in two months.
The Food and Drug Administration in its letter dated May 28, said the company failed to thoroughly investigate microbial contamination incidents in finished drug products and also cited inadequate cleaning practices.
This follows an FDA warning letter in April that flagged defects in Medline’s syringes used in heart procedures and warned of enforcement action if the issues were not addressed.
Medline did not immediately respond to a Reuters request for comment.
In its latest letter, the FDA said Medline’s probe into the contaminated samples was inadequate and faulted the company for not explaining why earlier corrective actions had failed, warning that such lapses may pose a patient safety hazard.
The FDA has directed Medline to provide an independent risk assessment of all contamination hazards in its manufacturing processes, equipment and facilities, along with a remediation plan and timelines.
The regulator said Medline’s manufacturing operators have routinely deviated from cleaning and disinfection procedures, and also flagged manufacturing lapses at other facilities in the company’s network.
It added that “repeated failures at multiple sites” demonstrate inadequate management oversight and control, and said the company should assess its operations to ensure they conform to FDA requirements.
Failure to address this matter may result in regulatory or legal action, the FDA said.
The company must respond within 15 days of receiving the letter.
(Reporting by Sneha S K; Editing by Vijay Kishore)
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