The Food and Drug Administration has warned McGuff Pharmaceuticals Inc. that it found significant violations of current good manufacturing practice (CGMP) regulations at the company’s manufacturing facility in Santa Ana, Calif., according to a warning letter posted Jan. 4 on FDA’s website.
FDA said it found the violations during an inspection of the Santa Ana facility that ended June 2, 2010. The company responded to FDA about the violations on June 16, 2010, but the agency said the responses lacked sufficient corrective actions.
Specific violations observed by the agency include, but are not limited, to the following:
- the company has ...
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