FDA warns device makers for GMP issues, unauthorized uses

The US Food and Drug Administration (FDA) recently warned a hemodialysis manufacturer for marketing their products without submitting a premarket notification for one of its products and a diagnostics firm for good manufacturing practice (GMP) and quality system issues.

Edge Biologicals

In a warning letter sent to Memphis, TN-based Edge Biologicals, FDA states that the company, which makes class I and class II in vitro diagnostics (IVDs) for medical applications, has repeatedly failed to adhere to good manufacturing practices. Agency inspectors investigated the company’s facilities between 20 March and 4 April and observed several repeat violations seen during previous inspections in 2015 and 2018, as well as repeat issues cited in a 2012 warning letter.

“You failed to validate the cleaning process for controlled environmental areas used for the aseptic processing of Mueller Hinton Agar antimicrobial susceptibility test culture media and other culture media devices,” said FDA. The company was also cited for failing to validate sterilization of tubing sets used in aseptic fill operations for culture media devices.

Among the other violations, Edge Biologicals was cited for failing to establish proper corrective and preventive action (CAPA) procedures, as well as procedures to ensure suppliers, contractors, and consultants meet their requirements. The company was given 15 business days to respond to the agency about the steps it is taking to bring itself into compliance.

Outset Medical

FDA also sent a warning letter to Outset Medical on 5 July, citing the San Jose, CA-based firm for marketing its Tablo Hemodialysis System and TabloCart with Prefiltration without the proper clearance or approval. Agency inspectors investigated the company between 17 January and 10 February and found that it had failed to submit a premarket notification for its Tablo Hemodialysis System and TabloCart with Prefiltration devices.

“You have not submitted any premarket notification to the agency for the TabloCart with Prefiltration,” said FDA. “However, the evidence and marketing materials reviewed at the inspection and found on your website [www.outsetmedical.com] on March 15, 2023, indicate that the TabloCart with Prefiltration is a device.”

FDA notes that the TabloCart with Prefiltration could be classified as a class II water purification system for hemodialysis and would require a premarket notification.

The Tablo Hemodialysis System is currently cleared for patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility or in the home. It is indicated for Intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED/ SLEDD), Prolonged Intermittent Renal Replacement Therapy (PIRRT) and Isolated Ultrafiltration.

However, based on promotional materials reviewed by FDA, the company has also indicated the product can be used for continuous renal replacement therapy (CRRT) treatment, which it has not been cleared for. Claiming CRRT treatment would require significant modifications to the device that would require additional review by the agency, FDA said.

“Patients who require CRRT are typically hospitalized with acute illness resulting in acute kidney injury and possible severe hemodynamic instability, and the devices that provide CRRT treatment have unique features to enable continuous treatment (> 24 hours) for this patient population,” said FDA. “Systems that cannot safely and reliably perform CRRT raise serious public health concerns when used for CRRT treatment, because failure of dialysis systems performing CRRT may result in fluid and electrolyte imbalances, inadequate ultrafiltration, infection, and patient harm/death.”

Outset Medical was also given 15 business days to respond to the warning letter.

Edge Biologicals Warning Letter

Outset Medical Warning Letter

FDA warns device makers for GMP issues, unauthorized uses

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