Enforcement In Brief: Key Points In Recent FDA Warning Letters And EU GMP Noncompliance Notices
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.
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Data integrity issues bedevil Chinese API firm Suzhou Pharmaceutical Technology and Japanese manufacturer Sato Yakuhin; inadequate sterility controls net warning letters for Brazilian firm Antibioticos Do Brasil, and US firms Horizon, Pharm D, and Aplicare; and lack of a functioning quality unit observed at Canadian firm Intega in FDA GMP warning letters issued in December and January.
New approach could eliminate minor differences among authorities, enabling pharmaceutical manufacturing processes to become truly global.