FDA criticizes drugmaker for 'significant violations'

The Food and Drug Administration has issued a stern warning to Amneal Pharmaceuticals for what it called “significant violations” of manufacturing standards, citing instances in which the drugmaker used contaminated IV bags while manufacturing certain of its injectable medications.

Amneal Pharmaceuticals develops, manufactures and distributes a wide range of pharmaceutical products, including both generic and specialty branded medicines, such as an auto injector for managing cluster headaches, as well as other injectables and biosimilars.

Amneal failed to establish laboratory controls that include scientifically sound specifications and testing procedures, the FDA said. That meant the drugmaker was unable to assure that its manufacturing components and materials were safe and pure.

During an inspection, the FDA saw deficiencies in staff members’ preparation and reading of bacterial endotoxin tests. One staff member failed to discharge a solution during water preparation for injection samples, which could compromise the accuracy and reproducibility of the test results, and failed to inspect the firmness of a gel-clot sample for endotoxin detection.

The primary microbiologist’s assessment was too rapid, the FDA said, and so the analyst responsible for the verification of the sample wasn’t able to adequately observe the process. Compounding the issue were insufficient documentation practices when recording sample results of bacterial endotoxin tests for water injection. 

The result of all this was visible particulate contamination.

Though these problems were recurring, the FDA determined that Amneal failed to conduct an adequate investigation, finding that the company’s risk assessment minimized the severity of the particle contamination.

“The presence of particulate matter in epidural injectable products can pose significant health risks to patients,” the FDA wrote in its letter to the drugmaker. “These risks are of particular concern for patients receiving long-term epidural therapy. There is a reasonable probability that particulate matter in the epidural space may cause an epidural inflammatory process, epidural abscess, or meningitis. Depending on the location of the epidural injection, the particles could potentially cause damage to the spinal cord including spinal cord infarction or permanent nerve injury.”

Amneal was aware of the contamination for more than a year prior to its 2024 investigation, the FDA found. 

The agency is asking the drugmaker for a comprehensive assessment of its system for investigating manufacturing deficiencies, a review of its materials system, and an assessment of its laboratory practices and documentation systems.

“Correct any violations promptly,” the FDA said. “FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance.”