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Enforcement In Brief: Key Points In Recent FDA Warning Letters And EU GMP Noncompliance Notices

 
• By Bowman Cox

Particulates, sterility failures and basic GMP noncompliance loomed large in FDA warning letters and EU GMP noncompliance notices to Facta Farmaceutici, Porton Biopharma, Antibioticos do Brasil, Euro Far, Ningbo Zhixin Bird Clean-Care, CTX Lifesciences and Pharmco Laboratories posted online last month.

FDA Jan. 13 gave Facta Farmaceutici SpA of Milan, Italy, a warning letter with lots of homework as a result of data integrity issues identified during an inspection a year earlier at the company’s plant in San Nicolò A Tordino, Italy.

During the inspection, FDA found an unofficial, uncontrolled spreadsheet of visible particle data that indicated multiple lots of sterile drug...

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• By Eliza Slawther

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• By Ewan Townsend

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‘Clean Sweep’ Of US CDC Vaccine Committee Puts Kennedy In Driver’s Seat

 
• By Bridget Silverman

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• By Eliza Slawther

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