FDA sends warning letter to Philly dye company, Abbey Color, about water problems in drug products POSTED: Wednesday, February 27, 2013, 11:47 AM

David Sell

Abbey Color, Inc., an industrial dye manufacturer in the Kensington section of Philadelphia, was sent a warning letter by the U.S. Food and Drug Administration that said the company failed to ensure adequate purity of the water used in drug products including those for eye exams.

Fluorescein is a sterile liquid dye used in eye exams that look at blood flow in the retina and choroid, the two layers in the back of the eye.

Eye drops are put directly in the eye to dilate pupils. With the patient's chin resting in the camera's chin rest, pictures are taken of the eye. Then the fluorescein dye is injected into a vein, usually near the elbow. A second set of pictures is taken as the dye moves through the blood vessels in the back of the eye.

The warning letter said the FDA inspected the facility on East Tioga Street from March 13-23, 2012. The company's reply to the FDA observations was not acceptable, the agency said.

"Your firm uses water in the final purification step of Fluorescein USP, an API [active pharmaceutical ingredient] intended for use in sterile drug products," the letter said. "However, your firm failed to demonstrate that your purified water system can consistently produce water that is suitable for use in the manufacture of this API.

"This is a repeat observation from the July 21-August 8, 2010 inspection. In your response to observations made at the 2010 inspection, your firm promised actions it would take to assure reliable water quality. However, those changes were inadequate, as you continued to get periodic out-of-specification (OOS) endotoxin and total organic carbon (TOC) test results."

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FDA HAS RAMPED UP INSPECTIONS OF APIs--From FiercePharma Manufacturing: FDA warning to Abbey questions quality of API for sterile drugs Warning Letter lists repeat violation on water quality February 27, 2013 | By Eric Palmer Read more: 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.

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Sign up for our FREE newsletter for more news like this sent to your inbox!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

Read more: FDA warning to Abbey questions quality of API for sterile drugs - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/fda-warning-abbey-questions-quality-api-sterile-drugs/2013-02-27#ixzz2MAm4Tpmh
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