Sarah Lunday Article – Alcon
The Henry J. Kaiser Family Foundation
Problems Involving Test Batches are Fixed, Drug Manufacturer Says
By Sarah Lunday
Reprinted with permission of The Dallas Morning News
Alcon Laboratories Inc. has received a warning letter from federal regulators, saying the drug maker failed to meet several quality and safety standards during a recent inspection.
The problems could alter the purity of the company’s products, according to the Nov. 17 letter from the Food and Drug Administration.
Alcon, a subsidiary of Swiss-based Nestle SA, produces eye-care products and technologies, including surgical instruments, prescription drugs and contact lens care products. It employs 2,600 people at its Fort Worth facility.
Company spokeswoman Mary Dulle said the problems found during the inspection involved test batches of products that would not have been distributed to consumers. She also said that Alcon has since remedied those problems.
“We absolutely believe that there is no possibility of contamination of our product,” Ms. Dulle said.
FDA investigators who visited Alcon’s drug and device manufacturing plant in October documented “serious deviations” from the agency’s regulations governing manufacturing quality, according to the letter.
Michael Chappell, Dallas district director for the FDA, said the Alcon case continues as an open investigation until regulators review the company’s corrections.
“We don’t necessarily consider the matter closed until we go back and check that they follow the criteria they said they would and that it would actually solve the problem,” Mr. Chappell said Friday the date specified in the letter as the deadline for Alcon to fix the defects.
Ms. Dulle declined to discuss the products involved in the testing cited by FDA inspectors.
The warning letter cited several areas of concern, including:
Failing to clean, maintain and sanitize equipment to prevent malfunctions or contamination.
Failing to establish appropriate written procedures to prevent microbial contamination in drug products.
Failing to assure and document that automated equipment used in manufacturing, processing, packaging and holding of drug products will perform its intended function.
Ms. Dulle said any problems investigators found were related to manufacturing lines that were being used for testing at the time of the inspection. Still, Alcon acted quickly to fix problems, Ms. Dulle said.
“It’s a warning letter, so they’re trying to bring something to your attention in a big way,” Ms. Dulle said. “We’re really trying to work with FDA so we don’t get these letters.”
The company has received two other warning letters since 1998 on separate incidents. In both cases, Alcon responded quickly and the cases were closed satisfactorily, Ms. Dulle said.