FDA Warns NuSil Technology About Manufacturing Practice Violations

The Food and Drug Administration has warned NuSil Technology LLC that it found significant violations of current good manufacturing practice (cGMP) regulations at the company’s active pharmaceutical ingredient (API) manufacturing facility in Bakersfield, Calif., according to a warning letter posted April 3 on FDA’s website.

FDA said it found the violations during an inspection of the facility that ended May 4, 2011. The company responded May 18, 2011, but the agency said the response lacked sufficient corrective actions.

Specific Violations.

Specific violations observed during the inspection include, but are not limited, to:

• did not have an adequate out-of-specification procedure to ...