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Apotex site in India is hit with FDA warning

 
• By Grace Montgomery

Apotex has received a warning letter from the US Food and Drug Administration (FDA) for its manufacturing facility in Bommasandra, near Bangalore, India, concerning its finished-dosage forms. Following an inspection at the firm’s Apotex Research Private Limited (ARPL) facility from 6-17 November 2017, the agency identified “significant violations” of current good manufacturing practice (cGMP), the heavily redacted warning letter reveals. The site was placed on import alert on 12 April 2018.

Apotex has received a warning letter from the US Food and Drug Administration (FDA) for its manufacturing facility in Bommasandra, near Bangalore, India, concerning its finished-dosage forms. Following an inspection at the firm’s Apotex Research Private Limited (ARPL) facility from 6-17 November 2017, the agency identified “significant violations” of current good manufacturing practice (cGMP), the heavily redacted warning letter reveals. The site was placed on import alert on 12 April 2018.

The FDA said that the firm’s investigation into out-of-specification (OOS) laboratory results and manufacturing deviations were “insufficient and do not...

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