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Home » FDA Cites Sterility Testing, Quality at Brazilian Drugmaker
FDA Cites Sterility Testing, Quality at Brazilian Drugmaker
September 8, 2009
Antibioticos do Brasil (ABL), a Brazilian manufacturer of sterile active pharmaceutical ingredients (APIs) and finished dosage products, did not adequately address GMP deficiencies even though it sent three response letters and three emailed corrective action updates following the FDA’s inspection of its facility.