RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
Regulatory Focus™ > News Articles > 2020 > 8 > Cord blood firm warned by FDA on Zika screening

Cord blood firm warned by FDA on Zika screening

Posted 25 August 2020 | By Kari Oakes 

Cord blood firm warned by FDA on Zika screening

A warning letter from the US Food and Drug Administration (FDA) warned a Puerto Rico-based firm for multiple violations related to human umbilical cord blood collection.
 
Banco Vida Corporation, located in San Juan, was inspected in September 2019 by investigators from FDA’s Center for Biological Evaluation and Research (CBER).  The increased risk for Zika virus for residents of Puerto Rico makes blood products from those individuals ineligible for use in human cell, tissue, or cellular or tissue-based products (HCT/Ps), said CBER. 
 
Additionally, Banco Vida had neither an approved biologics license application (BLA) nor an investigational new drug application (IND) on file, and the products were not intended for autologous or reproductive use, or for allogeneic use in close blood relatives. HCT/P use in these cases may have been exempted under 21 CFR 1271, noted CBER.
 
The inspectors also found multiple deviations from current good manufacturing practice (CGMP), including deficient donor screening practices and aseptic practices that were inadequate. In addition to inadequate screening for Zika virus risk, screening questions did not sufficiently address human transmissible spongiform encephalopathy risk.
 
The firm was also cited for lack of aseptic process validation, inadequate gowning procedures, and cleaning processes with “no data or rationale.”
 
Multiple problems with records and reports, including bath production and control records, were also observed by FDA inspectors. The agency acknowledged several communications from Banco Vida but found the firm’s responses inadequate and lacking. “Your responses also do not address your shipment of umbilical cord blood or umbilical cord blood intermediates for further manufacturing without an IND in effect to study these products, nor an approved BLA to lawfully market these products,” wrote the agency in the warning letter, which was issued on 12 August 2020.
 
Another warning letter released by FDA was directed at New Jersey-based Wintac Limited. Wintac maintains a drug manufacturing facility in Bangalore, India, which was inspected in February 2020.  
 
Inspectors at that time found that the firm’s investigations into problems with bacterial contamination of media fill units was inadequate. When looking into an issue with Ralstonia picketti contamination, Wintac’s staff only considered a limited portion of the processing strain, an approach that “lacked scientific justification for its narrow focus and for ruling out other meaningful failure modes,” according to the letter from FDA’s Center for Drug Evaluation and Research (CDER).
The plan to address contamination did not include corrective actions and preventive actions (CAPA), and the root cause analysis was inadequate, said FDA.
 
Smoke studies were also judged inadequate by FDA inspectors, who noted that the studies were not performed under dynamic conditions, did not adequately illustrate airflow, and did not address all regions of the aseptic processing area.
 
Media fills were also a problem for Wintac, according to inspectors. “Our inspection found that interventions and other operations simulated during media fills were not sufficiently representative of commercial aseptic manufacturing,” said the warning letter. The officials added, “If a media fill program fails to incorporate contamination risk factors and closely simulate actual drug product exposure, the state of process control and sterility assurance cannot be accurately assessed.”
 
Wintac was directed to provide adequate smoke studies and a thorough and independent risk assessment of contamination hazards related to its aseptic processes, equipment and facilities, along with other updates and remediation plans.
 
 
 
 

Tags: FDA, US

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe