Allergan Plant Failed to Test Products Properly, FDA Says

Allergan Inc.’s Puerto Rican manufacturing plant didn’t sufficiently test some eye ointments and solutions for changes in the products over time, U.S. government regulators found during an inspection late last year.

In addition, the Irvine-based company didn’t fully investigate or alert regulators about problems it did discover, the U.S. Food and Drug Administration said in a warning letter to the company. The letter, dated March 9, was released Tuesday by the agency.

The FDA said it relies on company warnings to protect the public from deteriorating products or significant chemical, physical or other changes that occur when a product already is on the market.

While Allergan corrected most problems uncovered during the November and December 1998 inspections, the FDA said it still has questions about the stability of some of the company’s ophthalmic products, such as Blephamide and Bleph-10.

Allergan is “in the process of writing a response to that letter,” said spokesman Ira Haskell. “We have put all necessary procedures in place and have taken steps to satisfy the FDA’s requests.”

The Puerto Rico plant, which has about 140 employees, is one of about 10 factories that Allergan operates worldwide. Its products are distributed throughout the United States and in other countries, Haskell said.

Allergan’s stock fell 50 cents to $94.69 a share on the New York Stock Exchange.

The FDA sends hundreds of warning letters to companies each year, and only a small minority of them result in significant agency action.