The US Food and Drug Administration (FDA) on Thursday released a warning letter sent late last month to San Diego-based umbilical cord blood product producer Genetech for selling unapproved products.
The warning letter comes as FDA and the Centers for Disease Control and Prevention have received numerous reports of safety issues including those involving microbial contamination and are aware of 12 patients who received Genetech products and subsequently became ill due to blood and other infections caused by a number of bacteria, including E. coli.
“Using the umbilical cord blood products to treat orthopedic conditions is not homologous use,” the agency explained in why it decided to send the warning letter.
FDA investigators also identified significant deviations from current good manufacturing practice (CGMP) and current good tissue practice (CGTP).
“For example, Genetech's deficient donor eligibility practices, unvalidated manufacturing processes, uncontrolled environment, lack of control of components used in production, such as the addition of [redacted], and lack of defined areas or a control system to prevent contamination and mix-ups, as described below, pose a significant risk that your products may be contaminated with microorganisms or have other serious product quality defects,” the warning letter says.
The firm was also found to have no quality control unit from the time manufacturing operations began in mid-2017 through the time of FDA’s inspection.
FDA also took issue with Genetech’s response from last August to a Form 483, explaining that documents submitted “do not demonstrate that you have corrected the deficiencies noted in the inspectional observations nor do they address your failure to have an IND in effect in order to study your products or your lack of an approved BLA in order to lawfully market your products.”
Meanwhile, the agency notified producers of regenerative medicine products, including stem cell products, that FDA is currently applying a risk-based approach to enforcement. FDA also made clear that the 36-month period during which the agency plans to exercise enforcement discretion will end in November 2020.
“Manufacturers and health care providers who have any uncertainty regarding the regulatory status of their products who have not already done so are encouraged to contact FDA well in advance of that date to determine if their products are subject to the agency’s premarket approval requirements,” FDA said.
Regenerative Medicine Update: Information for Industry on FDA’s Compliance and Enforcement Policy Regarding Certain Regulatory Requirements
Genetech Inc 11/29/18