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."
Total organic carbon tests measure the carbon in an organic compound and are used as one measure of water quality.
The warning letter was dated Feb. 19, 2013 and addressed to Richard S. Nielsen, the company owner and president. The certified letter requested a return receipt.
When a reporter called the company Wednesday morning and asked for Nielsen, Peter Hughes, a vice president and general manager, picked up the line.
Hughes said neither he, nor Nielsen nor another company executive 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 comment.
We followed up with the FDA's Philadelphia office, which is handling the case, to see if they received the return receipt on the certified mail, but we have not heard back.
In its press releases, Abbey Color says its hematoxylin stain is "certified by the Biological Stain Commission (BSC). Hematoxylin is the key ingredient in stains used by biological laboratories and pathologists for Pap smear tests." Abbey Color's Hematine is used for the dyeing of silk that is used in medical sutures and the company says it is a ChemStewards certified facility.
However, the FDA expects fixes to be made.
"You should take prompt action to correct the violations cited in this letter," the letter says. "Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction. 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 re-inspect to verify corrective actions have been completed."
A link to the warning letter on the FDA web site is here.