Par Health USA and Endo USA have received a formal warning from the U.S. Food and Drug Administration (FDA) due to serious violations detected at one of their factories in Michigan.
The administration explained that the inspection carried out in October inside the factory in Rochester revealed serious violations of Good Manufacturing Practices (CGMP) standards for pharmaceuticals, particularly with regard to drug manufacturing and sterilization processes.
The letter indicated that these violations included mishandling of sterile pharmaceutical products, in addition to weaknesses in the application of sterilization procedures and the maintenance of production environments free from microbial contamination, which led to excessive manual interventions during manufacturing, raising the likelihood of product contamination to an unacceptable degree.
The companies associated with the factory produce a wide range of common prescription drugs, including Tylenol with codeine, alprazolam, clonazepam, fluoxetine, and Adderall, as well as antibiotics such as doxycycline, drugs relied upon by millions of patients in the United States.
The Food and Drug Administration warned that any lapse in hygiene and manufacturing standards could lead to drug contamination or the presence of dangerous impurities, increasing the risk of infection or poisoning, especially in sterile or injectable drugs.
The letter also indicated that the factory does not have an effective quality system that ensures compliance with the required standards, and that its quality unit does not exercise its powers adequately, with weak administrative supervision of production processes.
The administration added that there are problems in the design of the ventilation and airflow systems inside the factory, along with inadequate procedures to prevent microbial contamination, and poor maintenance of sterilization rooms and areas, which threatens to maintain a safe production environment.
The administration also noted the absence of sufficient laboratory controls based on accurate scientific tests to ensure that products conform to quality standards.
According to standard procedures, companies are typically given 15 days to respond to such warnings, after having already been afforded ample opportunity to rectify the issues. The administration determined that the company's response to the initial warning was insufficient to address the underlying design and production problems.
For its part, the company explained that it had taken some corrective measures, including a temporary suspension of the production of some sterilizing medicines and a cessation of dealings with one of its glass suppliers after discovering defects in its products.
But the Food and Drug Administration stressed that these steps do not represent a radical solution to the problem, noting that the company is still dealing with the risks only partially without a comprehensive overhaul of its manufacturing processes and safety assurance.
