Latest FDA Warning Letters

FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

Dongying Tiandong Pharmaceutical Co. Dongying, Shandong China (11/10): FDA inspected the firm 10/2015 and documented significant deviations from GMPs for active pharmaceutical ingredients. For example, the firm failed to adequately investigate and document out-of-specification results and implement appropriate corrective actions. Additionally, the firm failed to ensure that test procedures are scientifically sound and appropriate to ensure that APIs conform to established standards of quality and purity.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm530369.htm

STI Pharma Langhorne, PA (11/21): FDA inspected the firm in July and documented serious violations of postmarketing adverse drug experience reporting requirements. The firm failed to develop adequate written procedures for the surveillance, receipt, evaluation, and reporting of adverse drug experiences. The inspection also determined that STI failed to document initial received dates for 70% of its adverse drug experience cases. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm530483.htm