West-Ward Closes Out Warning Letter After Quality Revamp

The FDA has closed out a warning letter issued to West-Ward Pharmaceuticals after the generic drugmaker completed a two-year overhaul of parts of its quality system.

Hikma Pharmaceuticals, which owns West-Ward, announced the closeout of the 2012 warning letter Apr. 2. The company says it spent tens of millions of dollars on remediation.

The warning letter focused on deficiencies at West-Ward’s Eatontown, N.J., facility. The FDA found during an inspection a flaw in standard operating procedures (SOPs) that could have contributed to variability in the thickness and hardness of in-process and finished drugs.

In response, West-Ward completely shut down production at the plant for several months in late 2012 and limited manufacturing for more than a year, West-Ward CEO Michael Raya told QMN Apr. 3.

The shutdown allowed West-Ward to reorganize its internal quality compliance structure and change leadership at the facility, Raya said. The company upgraded equipment and brought in subject matter experts from Hikma, as well as third-party consultants, to work through the problems.

To address the problem with the SOPs and in-process parameters, the company re-engineered all of its products so it can better manage the specifications for thickness and hardness.

Raya said manufacturing at the facility — which makes generic oral, liquid and injectable drugs — has been gradually increasing as its improvements have come online. Hikma said it expects to receive $170 million in revenue from generic drugs this year.

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