FDA issues warning to Philadelphia pharmaceutical dye manufacturer

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."

The letter, dated Feb. 19, was sent via certified mail addressed to company owner Richard S. Nielsen. Vice president and general manager Peter Hughes said Wednesday neither he nor Nielsen had received the letter.

"Until we receive the letter, we are not prepared to comment," Hughes said. "We've been working with the FDA for a few years on this product."

Asked about the water problem, Hughes again declined to comment.

The FDA's Philadelphia office handled the case. It was unclear Wednesday whether the agency got a return receipt for the letter as requested.

In its letter, the FDA said it expected improvements to be made.

"Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction," the letter said. "Other federal agencies may take this warning letter into account when considering the award of contracts. Additionally, FDA may withhold approval of requests for export certificates, or approval of pending drug applications listing your facility, until the above violations are corrected. FDA may reinspect to verify corrective actions have been completed."