Home » Rust, Debris in Hoses Lead to Warning for Italian Company
Rust, Debris in Hoses Lead to Warning for Italian Company
Ribbon SRL, an Italian antibiotics maker, has received an FDA warning letter for GMP deviations related to equipment cleaning and process simulations.
FDA inspectors observed that cleaned multiuse hoses, used in the production of cephalosporin intermediates, had white residue or brown rust-like residue on the connection surface and the interior of the transfer hose. The presence of rust, deterioration and debris in product contact equipment used to manufacture sterile drug products is unacceptable, according to the letter.
The FDA acknowledges details Ribbon provided on its general cleaning rules, but the company did not provide adequate information on its controls to ensure contaminated hoses are not used in manufacturing.
Drug GMP Report
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