Biologics

FDA Warns Cord for Life

David McFarland

— 3 min read
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FDA sent a 3/29 Warning Letter to Cord for Life, Altamonte Springs, FL, for manufacturing unapproved umbilical cord blood products in violation of current good manufacturing practice (CGMP) requirements, including failing to validate processes to prevent bacterial contamination, raising potential significant safety concerns that put patients at risk. In a statement, FDA commissioner Scott Gottlieb and CBER director Peter Marks say the agency issued 20 other letters to separate manufacturers and healthcare providers across the country who may be offering unapproved stem cell products, reiterating FDA’s compliance and enforcement policy.

“We remain very concerned that countless clinics across the country continue to market violative stem cell products to patients, claiming that they don’t fall under the regulatory provisions for drugs and biologics,” the two write. “That simply is not true. FDA has had final regulations in place for these products for well over a decade. We intend to take steps to help make sure that products are produced and marketed in compliance with statutes and our regulations. We’ll continue to conduct inspections, as appropriate, to help ensure such compliance. And we will not shy away from taking further steps when we see bad actors taking advantage of patients, and putting them at serious risk, for their own financial profit.”

The Cord for Life Warning Letter outlines the regulatory provisions that FDA says apply to the company’s umbilical cord blood derived cellular products for allogenic use. It also says agency investigators documented evidence of significant deviations from current good manufacturing practice regulations, indicating that use of the firm’s products raises potential significant safety concerns.

“For example,” the Warning Letter says, “Cord of Life’s unvalidated manufacturing processes, uncontrolled environment, and inadequate personnel aseptic practices … pose a significant risk that your products may be contaminated or have other serious product defects.” Specific deficiencies listed in an FDA-483 were: 

  •          failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
  •          failing to have an adequate system for monitoring environmental conditions in an aseptic processing area;
  •          failing to establish and follow written procedures for cleaning and maintenance of equipment used in the manufacture, processing, packing, or holding of a drug product;
  •          failing to establish written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess;
  •          failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity; and
  •          failing to establish and follow a written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates.

Cord for Life was told to respond with a list of specific steps it has taken or plans to take to correct the violations and prevent their recurrence, with documentation of each step and a timetable for completion.

In their statement, Gottlieb and Marks discuss the overall regulatory framework for stem cell products and their observations on what has occurred during a period of enforcement discretion for certain regenerative products regarding FDA’s IND and premarket approval requirements when use of the product does not raise reported safety concerns or potential significant safety concerns.

“We’ve seen modest progress by the industry in coming into compliance, but much more needs to be done,” they write. “There’s no room for companies that place patients at risk through products that violate our statutes and our regulations, including by not having in place an IND or biologics license. As we come up on the end of this period during which FDA intends to exercise enforcement discretion, we may take additional steps to delineate an efficient development path for promising products that pose lower risk to patients and that are being developed by sponsors who’ve engaged the regulatory process in a responsible manner by filing INDs…. But for sponsors whose stem cell products are regulated as drugs, devices, and/or biological products under the statutes and existing regulations, where the products create more significant potential risks because of the way they’re manipulated or delivered, and who haven’t engaged the regulatory process to properly develop these products, we’ll step up oversight.”

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