FDAnews Drug Daily Bulletin

Spanish API Maker Lands Warning Letter for GMP Deficiencies

Dec. 13, 2016

The FDA issued Spanish API maker Interquim a warning letter for failing to establish adequate cleaning procedures and maintain quality records data in violation of GMP standards.

As a result of those deficiencies, investigators noted that interior surfaces of the firm’s drug manufacturing equipment were not cleaned in accordance with the company’s standard operating procedures.

FDA investigators also found the company did not provide 12-month stability data for reprocessed APIs, calling into question whether those ingredients meet appropriate quality specifications.

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