Abbey Color Inc., a Philadelphia industrial-dye manufacturer, has been sent a warning letter by the U.S. Food and Drug Administration saying it has failed to ensure adequate purity of the water in an eye-examination product it makes.
Fluorescein is a sterile liquid dye used in assessing blood flow in the retina and choroid at the back of the eye.
The warning letter said the FDA inspected the company facility on East Tioga Street in the city's Kensington section March 13 to 23. The company's reply to the FDA's observations was not acceptable, the agency said.
"Your firm uses water in the final purification step of Fluorescein USP, an [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 [ingredient]. This is a repeat observation from the July 21-Aug. 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."