Alabama compounder slapped with FDA warning letter

FDA sign

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.

Whitepaper

Simplify and Accelerate Drug R&D With the MarkLogic Data Hub Service for Pharma R&D

Researchers are often unable to access the information they need. And, even when data does get consolidated, researchers find it difficult to sift through it all and make sense of it in order to confidently draw the right conclusions and share the right results. Discover how to quickly and easily find, synthesize, and share information—accelerating and improving R&D.

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.

Suggested Articles

Fujifilm has completed the first manufacturing facility in Japan to make drug-delivering liposomes to use for cancer fighting drugs it is developing.

Three Samsung execs face up to two years in jail for their roles in destroying data and documents at under-fire affiliate Samsung BioLogics.

The FDA has slapped a U.S. drug repackager, saying in a warning letter that its storage processes and equipment cleaning are not up to expectations.