FDA warning to Abbey questions quality of API for sterile drugs

The FDA says an active pharmaceutical ingredient maker in Philadelphia had yet to qualify that its purified water was in fact pure enough to make APIs two years after the agency noted a deficiency.

Abbey Color was told in a new warning letter posted to the FDA website this week that the agency is dissatisfied with the steps the company has taken to demonstrate that its water is suitable for use in manufacturing fluorescein USP, an API used in sterile drug products.

The inspection was conducted nearly a year ago, but the agency notes the company had promised in 2010 that it would make sure it had a reliable source of quality water. The most recent inspection found Abbey still passes spec endotoxin and total organic carbon test results. But inspectors found the operational parameters and effectiveness of an endotoxin removal unit had not been qualified and that Abbey was not monitoring the microbial and chemical attributes of the feed water.

The FDA also came down on the company for not getting to the root cause of its water-supply issues. The manufacturer was further criticized for not setting up an adequate program to monitor API stability that would determine how the API should be stored.

The FDA has been ramping up inspections of APIs, and drugmakers using additional user fees that kicked in this year from generic manufacturers. But that work is being put to risk by looming across-the-board budget cuts from the current sequestration fight in Congress. A recent Congressional Budget Office (OMB) ruling said that user fees have to be cut as well. Regulatory Focus recently figured the cuts would mean a loss of about $200 million from the FDA's base budget and an estimated $112 million (annualized) in lost user fees.

- here's the warning letter