Procedural issues yield 3-item 483 for Millennium.(HUMAN DRUGS)

Millennium Pharmaceuticals, Cambridge, MA New England District

Procedures covering handling of complaints and adverse events were deficient because they did not adequately detail the flow of information from Millennium Pharmaceutical's contract call center, FDA inspectors Brenda King and Amber Wardwell observed during their inspection Feb. 20-28, 2007.

Tracking information flow was required to assure that the company's Commercial Quality Assurance (CQA) section reviewed all reports of the possible failure of a drug to meet its specifications, the inspectors noted. Certain reports were being handled initially by other sections, such as Pharmacovigilance, and the procedures did not document the process by which such reports were then passed to CQA.

Millennium's written procedures for annual evaluations of complaints, recalls, returned or salvaged drug products and investigations was deemed "not adequate to conduct analysis of data to produce meaningful trending." Complaint data was not consistently analyzed each quarter or for the year. Annual Product Review procedure did not require evaluation of returned drug product.

The company had also failed to report all serious and unexpected adverse drug events to FDA within 15 calendar days, the FDAers added. Actual reports were submitted as much as 290 days after the 15-day period

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