FDA Warns California Drug Facility Of Continuing Violations, Rejects Response

The Food and Drug Administration told Laclede Inc. that it found significant violations of current good manufacturing practice (cGMP) regulations at the pharmaceutical manufacturing facility in Rancho Dominguez, Calif., and noted that corrective actions taken so far are insufficient, according to a warning letter posted March 12 on FDA’s website.

In addition to violating cGMP, the company manufactured and marketed both over-the-counter and prescription drug products without an approved application, the agency said.

Insufficient Response.

FDA said it found the violations during an inspection that ended June 27, 2012. The agency said it has conducted a detailed review of the ...