FDA Warning Letters Cite Bristol Myers Factory, Enfamil Packaging

Drug maker Bristol-Myers Squibb Company has been cited by US regulators for a variety of so-called “deficiencies” at its manufacturing plant in Puerto Rico, said Business Week. Among the complaints, g<"http://www.yourlawyer.com/practice_areas/defective_drugs">lass particles in drug vials and potential contamination of sterile drug products, added Business Week.

In its warning letter to the drug maker, the US Food and Drug Administration (FDA) told Bristol-Myers Squibb that the agency could suspend new product approvals if the problems are not immediately corrected, noted Business Week.

The agency investigation was announced at an analyst conference call about the drug maker’s third-quarter earnings and was disclosed by the firm’s Chief Executive, Lamberto Andreotti, said Business Week. According to Andreotti, the firm advised the agency about its corrective measures and pointed out that it was told it must resolve the issues before the agency will approve a new biologic drug, developed to prevent organ rejection, for sale, explained Business Week.

Meanwhile, according to Reuters, Mead Johnson Nutrition Company, “spun off” Bristol-Myers Squibb Co. this year, has been accused by the FDA of failing to provide it with mandated data on how some of its Enfamil—an infant formula product—are assembled.

The FDA said that Mead Johnson did not provide it with details on the plastic tubs and lids used in Enfamil Premium Infant, Enfamil Gentlease, and Enfamil A.R., said Reuters. That requirement should have been met when Mead Johnson advised the FDA that it was planning on blending and packaging the formula powder products at a plant in Evansville, Indiana, said the October 18 FDA warning letter, wrote Reuters. The letter was posted on the FDA website yesterday.

The Enfamil formula products are packaged in pouches; however, the product’s labeling states that consumers can also store the powder in the plastic tubs, said the FDA, reported Reuters. The issue is that Mead Johnson never indicated the tubs or lids as possible food-contact surfaces and did not evaluate the plastic used to make the lids and tubs, explained Reuters.

“Our label recommends that parents keep the powder in the pouch,” said Mead Johnson spokesman Chris Perille in an email, quoted Reuters. “However, we recognize that consumers may choose to empty the pouch into the tub, and we therefore provided instructions on the label on how to do so safely,” Perille added. According to Perille, the lids and tubs are created with FDA-approved materials and Mead Johnson is responding to the agency on the matter, reported Reuters.

We recently wrote that Bristol-Myers Squibb’s blood pressure medication Avalide, was recalled in the US and Puerto Rico over a potential variability in levels of the active ingredient in Avalide, irbesartan, which could result in slower dissolution.

Just prior, we wrote that Bristol-Myers Squibb implemented a voluntary recall of certain lots of Coumadin®. The FDA previously said that the recall was a precautionary measure based on the company’s determination that some tablets, over time, may not meet specifications for isopropanol, used to maintain the active ingredient, Coumadin, in the crystalline state, and could affect the therapeutic levels of the active ingredient.

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