FDA Warns Drug Manufacturer Of Violations at Pennsylvania Facility

The Food and Drug Administration has warned Hawkeye-Jensen Inc. that it found significant violations of current good manufacturing practice (cGMP) regulations at the company’s pharmaceutical manufacturing facility in Shartlesville, Pa., according to a warning letter posted Feb. 15 on FDA’s website.

Additionally, FDA said the company is marketing an antiseptic wound cream that is considered an unapproved new drug.

FDA said it found the violations during an inspection of the facility that ended Aug. 10, 2010. The company responded to FDA about the violations Aug. 20, 2010, but the agency said the responses lacked sufficient corrective actions.

Specific violations observed ...