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Immucor Gets FDA Warning Letter

May 14, 2008 | Parker Waichman LLP

Immucor, a maker of blood-testing supplies, has received a warning letter from the Food & Drug Administration (FDA) because of problems with its manufacturing procedures.  The letter, dated May 2,  said Immucor had 15 working days to make corrections. Should it fail, the FDA warned Immucor it could face license suspension and/or revocation, seizure and/or injunction.

The warning letter stems from an FDA inspection of Immucor in  Norcross, Georgia, between January 8 and January 17, 2008.  The FDA warning letter says the company allowed products into its inventory that had previously tested positive for microbial growth and were put on hold by the FDA. The blood reagent products were allegedly allowed back into Immucor's inventory before the FDA could complete its investigation. The FDA also claims Immucor "failed to establish and maintain procedures for implementing corrective and preventive action, including requirements for investigating the cause of nonconforming product and identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems."

The FDA acknowledged that it received written responses from Immucor that address the violations found during the January inspection.  However, the agency said those responses did not provide sufficient detail to fully assess the adequacy of your corrective actions. For example, the FDA said the responses failed to discuss implementation of adequate quality assurance oversight to ensure prompt identification, correction, and follow up to problems associated with the manufacture of Immucor products.

Immucor Chief Executive Officer Gioaccino De Chirico said in a press release that the company was working to make sure it was in compliance with the FDA.  "We take our regulatory responsibilities very seriously and are working diligently to respond to the FDA as soon as possible," De Chirico said.  The press release also noted that the FDA had not recalled any Immucor products, or placed any limitations on the manufacture or distribution of any of our products.

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