Warning Letter Roundup: FDA Enforcement And Compliance In Brief
Executive Summary
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.
You may also be interested in...
FDA GMP Warning Letters Review: Foreign Drug Product Firms Hit Hard On GMP Basics
Many of the 30 drug product firms that received FDA warning letters in 2016 were foreign cosmetics and hygiene manufacturers that appeared to need education on US GMP requirements. Another major focus in letters to drug product firms last year was sterility assurance in the US and abroad.
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.
FDA DRUG cGMP WARNING LETTERS FROM FY 2009
FY 2009 FDA drug cGMP warning letters listed by the type of facility involved