Exclusive: Black Specks, Unsuitable Chemicals & Repeat Violations at America’s Key Heparin Factory

Smithfield Bioscience, a specialized subsidiary of Chinese-owned Smithfield Foods, was cited for significant violations at its Cincinnati manufacturing facility. The operation is tied to what the company describes as the largest US-based supply of heparin sodium active pharmaceutical ingredient (API).

Heparin is a widely used anticoagulant, or blood thinner, administered in hospitals to prevent blood clots. It is estimated that 12 million patients in the United States are exposed to heparin each year, particularly in settings like surgery, dialysis, and intensive care. This represents approximately one-third of patients to visit American hospitals each year.

The HighWire obtained the FDA inspection report through a Freedom of Information Act (FOIA) request, detailing findings from a December 2025 inspection that raise concerns about quality control at a key point in the heparin supply chain.

The inspection report describes systemic failures in the company’s ability to control critical manufacturing parameters, including time, temperature, and process loads, which resulted in high deviation rates and repeated failed batches.

One of the more concerning findings involves the use of supplier-provided ethanol identified in the report as “unsuitable for use in the production of Active Pharmaceutical Ingredients.” According to the FDA, the supplier explicitly stated it does not follow Good Manufacturing Practices (GMP) and does not produce pharmaceutical-grade material. Despite this, Smithfield Bioscience proceeded to qualify and use the supplier without obtaining a certificate of analysis, conducting a risk assessment, or performing additional testing.

The report also details instances of visible contamination. Investigators noted that the company failed to identify “black specks” observed in products during manufacturing. Despite testing, the firm did not determine the nature or source of the particulate matter. Instead, the affected batches were reprocessed and ultimately released, without a confirmed root cause.

The report notes that the “failure to conduct thorough investigations into unexplained discrepancies and the failure of the batch to meet any of its specifications” is a repeat observation that was also noted in the FDA’s 2019 report. The inspector in the 2019 report also notes failures to investigate OOS results.

In pharmaceutical manufacturing, unidentified particulate contamination typically requires full investigation before any product can be considered suitable for release. The FDA cited this as part of a broader failure to conduct thorough investigations into discrepancies and out-of-specification (OOS) results. The December inspection report does not link these findings to any specific patient harm at this point in time.

Heparin is derived from porcine intestinal tissue, which is more complex and sensitive to variability in sourcing, purification, and processing. Small inconsistencies or impurities can have significant effects on patients.

Unfractionated heparin is widely regarded as a high-risk drug with a narrow therapeutic window, meaning that small deviations in composition or potency can impact both safety and effectiveness.

In 2007–2008, contaminated heparin linked to upstream supply issues resulted in 350 adverse reactions and 150 deaths in the United States. Investigations later determined that the contamination involved an adulterant that was difficult to detect using standard testing methods at the time.

More recently, in 2024, Baxter issued a nationwide recall of a lot of heparin sodium injection due to the potential presence of elevated endotoxin levels, bacterial toxins that can cause fever, shock, and, in some cases, multi-organ failure. No adverse events were reported in that recall, but it was tied to the same Chinese manufacturer responsible for the 2008 heparin contamination crisis.

Smithfield Bioscience operates in Cincinnati, Ohio, but is owned by Smithfield Foods, which was acquired by a Chinese firm in 2013. At the time of the acquisition, some U.S. lawmakers raised concerns about the potential implications for the domestic heparin supply. They were concerned that a Chinese-owned company would prioritize China in the event of a heparin shortage, which could be a national security issue.

Smithfield Foods is the largest hog producer and pork processor in the United States and globally. Its bioscience division specifically extracts pharmaceutical ingredients from animal tissues. A total of six observations were made by the inspectors in December that indicate serious potential issues with upstream contamination. That requires adequate downstream safeguards to detect impurities and inconsistencies, protecting patients from harm or inefficient medicine.

The inspection report also notes that the company’s lab records lack a second signature, indicating they are not being properly reviewed. There are no safeguards to protect information from being accessed or changed by anyone who happens to be in the room. Lastly, the report says the firm is using equipment that lacks audit-trail capabilities or unique logins.

Smithfield Foods is facing pressure from President Trump and some Congressional representatives for being a Chinese-owned company that is also a leading pork producer in the country. Smithfield Bioscience is a leading US producer of heparin, so the FDA may continue issuing warnings to the firm to improve its manufacturing and testing processes, rather than taking aggressive action that could disrupt the domestic supply of a critically used drug.