THIS DOCUMENT LISTS OBSERVATIONS MADE BY THE FDA REPRESENTATIVE(S) DURING THE INSPECTION OF YOUR FACILITY. THEY ARE INSPECTIONAL OBSERVATIONS, AND DO NOT REPRESENT A FINAL AGENCY DETERMINATION REGARDING YOUR COMPLIANCE. IF YOU HAVE AN OBJECTION REGARDING AN OBSERVATION, OR HAVE IMPLEMENTED, OR PLAN TO IMPLEMENT, CORRECTIVE ACTION IN RESPONSE TO AN OBSERVATION, YOU MAY DISCUSS THE OBJECTION OR ACTION WITH THE FDA REPRESENTATIVE(S) DURING THE INSPECTION OR SUBMIT THIS INFORMATION TO FDA AT THE ADDRESS ABOVE. IF YOU HAVE ANY QUESTIONS, PLEASE CONTACT FDA AT THE PHONE NUMBER AND ADDRESS ABOVE.

DURING AN INSPECTION OF YOUR FIRM (WE) OBSERVED:

1. Regarding Fluvirin Sterility Investigation #R/0198/10/04 dated October 9^th 2004:
   1. The Fluvirin Sterility Failure Investigation Report states (in part) that [ Redacted ] fumigation took place on May 17, 2004 as a corrective action to increased levels of Gram negative organisms (including Serratia spp) during April and May. The area fumigated was the formulation suite. The firm deemed that the fumigation “was successful, as confirmed by ongoing environmental monitoring” and that “it should be noted that there are no confirmed isolates of Serratia spp. within the Grade [ Redacted ] LAF unit where aseptic connections are made.” The firm further deems this as “a key assessment criteria for further batch processing as part of the Quality Assurance Process”. This investigation conclusion is not supported and information reported is inaccurate, in that:
      1. the firm does not report that Gram negative rods, oxidase negative, were actually isolated in the formulation areas after the fumigation, further Gram negative rods identified as Serratia spp. were also isolated, and
      2. there is no evidence that the firm took further action to correct continued excursions of alert and action levels in formulation rooms [ Redacted ] and [ Redacted ] from May 2004 through September 2004. The firm continued to experience alert and action level excursions for Gram negative organisms, including but not limited to, Serratia spp.
   2. Regarding retest performed on the sterility test failures for four of nine final vial product lots, there is no investigation into the mixed pass and fail sterility test results for the original two lots and two “sister” lots associated with the failed monovalents.
      
      The original two failed lots [ Redacted ] were retested [ Redacted ] times the normal test sample size (normal test sample size is [ Redacted ] vials). The “sister” lots [ Redacted ] of the two original failed lots were also retested [ Redacted ] times the normal test sample size. Results are as follows:

EMPLOYEE(S) NAME AND TITLE (Print or Type)
Omotunde O. Osunsanmi, CSO
Paula A. Trost, CSO
John D. Finkbohner, Ph.D. Supv. Chemist
David S. Cho, Ph.D., Microbiologist
Mark A. Elengold,Deputy Director Oper., CBER

The observations of objectional conditions and practices listed on the front of this form are reported:

1. Pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, or
2. To assist firms inspected in complying with the Acts and regulations enforced by the Food and Drug Administration.

"Upon completion of any such inspection of a factory, warehouse, consulting laboratory, or other establishment, and prior to leaving the premises, the officer or employee making the inspection shall give to the owner, operator, or agent in charge a report in writing setting forth any conditions or practices observed by him which, in his judgement, indicate that any food, drug, device, cosmetic in such establishment (1) consists in whole or in part of any filthy, putrid, or decomposed substance or (2) has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. A copy of such report shall be sent promptly to the Secretary."