The Food and Drug Administration has warned APP Pharmaceuticals LLC that it found significant violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals at the company’s manufacturing facility in Grand Island, N.Y., according to a warning letter posted Feb. 28 on FDA’s website.
FDA said it found the violations during an inspection of the facility that ended July 8, 2011. The company responded to FDA about the violations July 29, 2011, but the agency said the response lacked sufficient corrective actions.
Specific Violations.
The violations observed during the inspection include, but are not limited, to:
- failure to thoroughly ...
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