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.
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.
“Following an inspection of our ReadyCare Waukegan facility (in Illinois), we implemented significant improvements in our production processes and plant operations to ensure the highest levels of quality,” the company said in an emailed response.
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.
The company said it is continuing to fully engage with the FDA related to both its Waukegan facility and its other drug manufacturing sites.
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 in Bengaluru; Editing by Vijay Kishore)
Comments