Warning Letter Prompts Hikma to Halt Production at NJ Generics Plant

Hikma Pharmaceuticals will cease commercial production at its Eatontown, N.J., plant through mid-January to focus on bringing the facility back into compliance with GMP regulations following a February 2012 warning letter.

Further, FDA observations from a recent inspection showed additional compliance work is required and halting production will allow it to be completed faster, Hikma said. The company could not be reached for additional information on the planned compliance fixes.

The remediation and additional restructuring for its generics business are expected to cost about $5 million this year, the company said.

Time is money. Bringing your manufacturing to a grinding halt can hurt the bottom line. What would you do if you knew the five hottest areas of concern showing up in FDA warning letters?

Knowledge is power, and FDAnews’ must have report, FDA Drug Enforcement: An Analysis of Warning Letter Trends, will give you the knowledge you’ll need to bypass possible warnings in the future.

FDA Drug Enforcement dives deep into the substance of warning letters, teasing out trends buried in swamps of bureaucrat-speak, including:

• GMP inspections,
• Clinical trials; and
• Drug-product marketing.

While it is only the tip of the iceberg, this collection of material will help avoid a possible catastrophe. Order your copy today!