Tuesday February 22, 4:02 pm Eastern Time Abbott plant cited for quality control lapses WASHINGTON, Feb 22 (Reuters) - Federal health officials have warned Abbott Laboratories Inc. (NYSE:ABT - news) about quality control problems involving production of a blood chemistry test at a Texas manufacturing plant.
In a nine-page letter released Tuesday, the Food and Drug Administration charged that Abbott failed to establish and maintain procedures to correct problems in the production of its Alcyon Analyzer at a facility in Irving, Texas.
The letter, one of hundreds the FDA sends each year, was sent February 7 to Abbott Chief Executive Miles White and released by the FDA's Freedom of Information office Tuesday.
The violations cited ``may be symptomatic of serious underlying problems in your establishment's manufacturing, quality assurance and/or quality management systems,'' the letter said.
The problems were uncovered during FDA inspections from October 26 to December 22, the letter said.
Last November, Abbott agreed to pay a $100 million federal fine to resolve allegations that it did not follow good manufacturing practices at a medical-testing device plant in Illinois. Abbott did not admit to any violations.
The Texas inspection was part of FDA's efforts to make sure Abbott was implementing new quality assurance procedures at all its manufacturing facilities, Abbott spokesman Joe Daab said.
``That was always our intent,'' Daab said, adding ``we plan on fulfilling all FDA requirements as quickly and as comprehensively as possible.''
Daab also noted that Abbott recalled the Alcyon device from the U.S. market for business reasons but still sells it overseas.
In the letter, FDA officials acknowledged the recall but said ``we remain deeply concerned that these deviations may impact other devices made at the Irving, Texas facility,'' the letter said.
The warning letter released Tuesday is the fourth letter sent to Abbott since last March.
So what is really causing the stock to move? I heard about ABT taking over for 10 years, enough already! Somethings up, and I hope it isn't ABT. I'm not sure who's management is worse. Will I take $48, think of all those options at $58...do I hear a flush in the background?
A few months ago Paul Craig Roberts wrote a great article in IBD about how the federal and state governments have found it easier to plunder industries than to tax them. Tart it up with whatever Latin legalese you wish, the fine was simply a vehicle to loot Abbott and ease the budget.
Much of the regulation nowadays has nothing to do with the quality of a product or a specific batch of a product, or its suitability for its intended use, but rather with the nature of the internal paperwork guiding the process for producing it.
If a pharaceutical product is pure, does what it was intended to do, meets its release specifications and remains usable for the duration of its labeled dating, it is a quality product. A diagnostic that gives a good result, meets its release specs and performs within spec for its labelled shelflife is also a quality product.
The rest of the requirements are just bureaucratic Catch 22, with Big Brother telling (in this case highly successful) firms how they ought to run their business.
The FDA really does not have a vendetta. The GMP regs that the diagnostics industry is suppose to follow were enacted because the industry was having many recalls. When this was investigated the FDA found that manufacturing practices were lax and that manufactures did not have the proper controls in place. If you follow the rules, you don�t get wacked.