
Fresenius Kabi Receives Warning Letter from FDA on Fenwal Blood Products
The United States Food and Drug Administration (FDA) has issued a warning letter to Fresenius Kabi tied to significant deficiencies at its Puerto Rico manufacturing site. And highlighting the risk of contamination in blood pack products purporting to be sterile. The warning letter comes following a recently conducted an inspection of a Fenwal manufacturing site located in Maricao, Puerto Rico, between September 12, 2022, and September 24, 2022. Fenwal is a subsidiary of Fresenius Kabi. The FDA inspection revealed significant deviations from current good manufacturing practice (CGMP) requirements in the manufacture of blood-pack units (BPUs) and related products, including Alyx component solutions, Amicus component solutions, and InterSol, a platelet additive solution. The FDA highlighted in the warning letter that these deviations raise concerns about the safety and quality of the products. Patients receiving blood transfusions are at exceptionally high risk for infections and sepsis, one of the leading risks associated with blood transfusion, especially in platelet transfusions.
The CGMP deviations identified by the FDA during the inspection include:
- Failure to Follow Established Procedures and Investigate Discrepancies: Fenwal International, Inc. failed to follow established, approved written procedures and thoroughly investigate any unexplained discrepancy or the failure of a batch to meet specifications. This includes instances where batches of terminally sterilized products exceeded bioburden action limits, and investigations did not adequately determine the root cause.
- Failure to Test In-Process Materials: The company did not test in-process materials for identity, strength, quality, and purity during the production process. This includes failing to reject lots with in-process bioburden results exceeding acceptable limits.
- Failure to Prevent Microbiological Contamination: Fenwal International, Inc. did not establish and follow appropriate written procedures to prevent microbiological contamination of drug products purporting to be sterile. This includes not ensuring that the sterilization process can achieve the required sterility assurance level (SAL) in the presence of high bioburden levels.
- Failure to Maintain Equipment and Facilities: The company failed to clean, maintain, and sanitize equipment and utensils at appropriate intervals to prevent contamination that could alter the safety, identity, strength, quality, or purity of drug products. This includes issues like damaged HEPA filters and residues on equipment surfaces.
- Failure to Maintain Buildings: The facility was found in a state of disrepair, with gaps in the ceiling, cracked surfaces, and other structural issues that could potentially lead to contamination.
- Failure to Establish Laboratory Controls: The company did not establish laboratory controls with scientifically sound and appropriate specifications, standards, and test procedures to ensure product quality.
The FDA’s letter also highlighted that Fenwal International, Inc. had previously failed to adequately correct similar violations observed during past inspections. Fenwal received a similar warning letter on June 14, 2020. The agency noted that these violations could pose a significant risk of product contamination. The company was given the opportunity to address these issues within fifteen working days of receiving the letter. Fresenius Kabi has not yet issued a statement in response to the warning letter. Failure to respond to the warning letter may result in regulatory action, including seizure and/or injunction against selling affected products.
This has been a tough week on the regulatory front for Fresenius Kabi. Earlier this week New York Attorney General Letitia James, Georgia Attorney General Christopher Carr, and New Jersey Attorney General Matthew Platkin have jointly filed a complaint against Fresenius Vascular Care, Inc. (FVC) and several affiliates, including one of its New York-based executives, Gregg Miller, M.D. The complaint alleges that FVC engaged in a scheme to subject Medicaid recipients with end-stage renal disease (ESRD) to unnecessary surgeries and defrauded the New York state Medicaid program.