Eagle Pharmacy, an Alabama drug compounder, was slapped with a warning letter by the FDA for unsanitary conditions and failing to register new compounds.
The letter, which was posted on the FDA’s website, cited the Hoover, AL-based compounder for “serious deficiencies” in its manufacturing process. During an August 2015 inspection, the regulatory agency observed an employee “moving their arm over open vials during aseptic filling.”
The inspector also saw an employee place materials onto a critical work surface without first disinfecting the materials. Additionally, media plates used for personnel and environmental monitoring didn’t contain disinfectant neutralizers, which could potentially bias results.
The agency also cited Eagle Pharmacy for failing to show correct procedures to ensure its products are produced in a sterile environment, which poses a risk of contamination.
The company was also cited for not having FDA-approved applications for drug products and misbranding its compounded products.
The agency noted in its warning that some of Eagle’s responses to the inspection fell short of FDA regulations and without prompt action the company could face legal action, including seizure of the facility. It said it will re-inspect the site.