www.fdanews.com/articles/192595-fda-requests-recall-of-florida-compounders-sterile-products
FDA Requests Recall of Florida Compounder’s Sterile Products
September 4, 2019
Acting FDA Commissioner Ned Sharpless flagged “significant quality and sterility concerns” surrounding a Melbourne, Florida outsourcing facility, as the agency sought a recall of all sterile products compounded at the facility.
Sharpless cited serious contamination risks the agency discovered during a May inspection of Pacifico National, doing business as AmEx Pharmacy, and repeated a June 28 public advisory to avoid the products.
The FDA investigators found a rusted supply cart, residue buildup on a plexiglass window and a cleanroom ceiling and a failure to follow complaint handling procedures, among a host of other issues.