FDA WARNING_LETTER - Immucor, Inc. - January 17, 2008

The FDA conducted an inspection of Immucor, Inc. in Norcross, Georgia, from January 8 to January 17, 2008, identifying violations in the manufacture of serological reagents, classified as medical devices. The inspection revealed violations of Section 501(h) of the FD&C Act and deviations from 21 CFR Part 820 (CGMP), leading to the issuance of a Form FDA 483. Significant deficiencies included the failure to establish and maintain procedures for controlling nonconforming product (21 CFR 820.90), managing changes to specifications or processes (21 CFR 820.70(b)), and handling complaints to determine Medical Device Reporting (MDR) requirements (21 CFR 820.198(a)(3)). Additionally, the firm failed to implement adequate corrective and preventive action procedures (21 CFR 820.100) and did not submit an MDR to FDA within 30 days for a device malfunction likely to cause serious injury (21 CFR 803.50(a)(2)). While Immucor submitted written responses, the FDA deemed them insufficient, particularly regarding quality assurance oversight. The firm is required to take prompt corrective action and notify the FDA within 15 working days of steps taken to correct violations and prevent recurrence. Failure to comply may result in regulatory actions, including license suspension/revocation, seizure, or injunction, and may impact federal contract awards.