Cipla's new U.S. plant received Form 483 just ahead of deal

According to the document, FDA inspectors were in the InvaGen plant in Hauppauge, NY, for two weeks in May. What concerned them is that InvaGen was routinely using its change of control procedures to deal with manufacturing issues, instead of its Corrective and Preventive Action (CAPA) system, which is intended to track and evaluate over time whether corrective actions are actually making a difference.

Inspectors also criticized the facility management for failing to find the root cause for the discoloration of hydroxyzine HCI tablets after receiving several complaints and inspectors said it failed to investigate issues with its contract packager after complaints that two different types of tablets were found in a sealed bottle of amlodipine.

The half-billion-dollar deal included both InvaGen and Exelan Pharmaceuticals, a Lawrenceville, GA, operation that markets and sells InvaGen's products into the government and institutional markets. Cipla also picked up about 500 employees as well as InvaGen's portfolio of 32 products on the market and 30 in the pipeline.

Source: Fierce