The manufacturer of products sold under brand names including Tylenol with codeine, Adderall, and Klonopin has received a warning letter from the U.S. Food and Drug Administration (FDA) for 'significant violations' at its manufacturing facility in Rochester, Michigan.
FDA Inspection Uncovers Violations
The letter, sent earlier this month to Par Health USA, LLC and Endo USA, Inc., follows an inspection in October that uncovered multiple breaches of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. The FDA cited improper handling and manufacturing of sterile drug products, as well as failures in aseptic processes and practices necessary to keep products and environments free from disease-causing pathogens.
According to the FDA, the violations resulted in 'excessive and high-risk manual interventions' during manufacturing, creating 'unacceptable hazards to product sterility.' The agency also noted inadequate airflow and design flaws that could lead to unsanitary contamination.
Popular Drugs Affected
Par Health manufactures dozens of widely used generic drugs, including acetaminophen and codeine tablets (sold as Tylenol with codeine), alprazolam (formerly Niravam), clonazepam (Klonopin), fluoxetine (Prozac), Adderall (both regular and extended release), and broad-spectrum antibiotics like doxycycline. Tens of millions of Americans rely on these medications, and failures in sanitation or manufacturing guidelines could result in contamination with harmful impurities or unsterile products, posing toxin or infection risks, particularly for injectable drugs.
Quality System Deficiencies
The FDA's letter stated: 'Significant findings in this letter demonstrate that your firm does not operate an effective quality system in accord with CGMP. In addition to the lack of effective management oversight of your production operations, we found your quality unit is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities.' The agency urged executive management to 'immediately and comprehensively assess your company's global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements.'
Additional Violations
The FDA also identified failures to establish and follow procedures to prevent microbiological contamination of sterile drugs, deficiencies in maintaining aseptic cleanrooms and equipment, and inadequate protection of sterile areas. Furthermore, the company failed to implement laboratory controls with 'scientifically sound and appropriate' standards and testing to ensure product quality.
Company Response Deemed Inadequate
Business owners typically have 15 days to respond to FDA warning letters, which are often issued after months or years of unresolved issues. Par Health responded to the FDA's initial notice in November, but the agency deemed the response 'inadequate' because it 'does not overcome fundamental design flaws.' The company implemented some changes, including temporarily suspending manufacture of aseptically filled products and ceasing work with a third-party glass supplier that had defects. However, the FDA stated that the company is 'attempting to partially mitigate significant... hazards' rather than making comprehensive process changes. The letter concluded: 'Overall, your response fails to address how you will ensure adequate aseptic processing operations and collect meaningful data to support your aseptic processes.'
