Amneal Pharmaceuticals FDA Report Absolutely Disqualifying.
Their social media is locked from comments and their website is the shadiest I ever seen.
Their facilities have contaminated products and it is literally a scam company.
Snipped of the report: “Your firm failed to conduct an adequate investigation into recurring problems with visible particulate matter contamination. In 2024, your firm initiated an investigation when two batches of ropivacaine hydrochloride injection, supplied in polypropylene bags, exceeded your acceptance criteria for visual inspection. You identified the polypropylene bags as the source of the inordinately high levels of particulate contamination (predominately, white fibers). You performed an additional visual inspection and conducted a risk assessment that you believed justified releasing these batches. However, your risk assessment was inadequate as it minimized the severity associated with particle contamination in a sterile injectable drug product that can be administered into the epidural space.”
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amneal-pharmaceuticals-llc-709894-08272025
