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

Last month India's Cipla announced it had struck a $550 million deal to buy its first U.S. property, InvaGen Pharmaceuticals, getting a 350,000-square-foot manufacturing facility and portfolio of drugs. What it left out of the announcement is that its first U.S. manufacturing operation came with some FDA concerns. The company received a Form 483 this spring for that plant, which the FDA did not post until two weeks after the deal was disclosed.

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.

The FDA inspectors pointed out that between Oct. 26, 2010 and the time of the inspection in May, the firm had used its CAPA only 8 times to deal with issues, with the last being more than two years earlier. But it said the company turned to its change of control procedures instead of the CAPA to see if employee retraining was effective after 10 laboratory reports failures and 56 lab deviation notices in 2014. It also was not used to check the root cause and corrective actions in 90 lab deviation notices in 2014 which led to sample retesting.

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.

While other Indian drugmakers have had U.S. manufacturing operations for years, the InvaGen deal gave Cipla its first. It gets a plant with three units on Long Island, NY, with a production capacity of 12 billion tablets and capsules per year. When it announced the deal in September, Cipla said it was just its second "landmark acquisition" in its 80-year history.

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.

- here is the Form 483