Home » FDA Requests Recall of Florida Compounder’s 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.
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