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FDA completes Wyeth GMP inspection

Executive Summary

FDA concludes its re-inspection of the Guayama, Puerto Rico manufacturing facility, Wyeth says April 5. The site passed a GMP inspection by EMEA at the end of March; the firm hopes to address FDA's observations in writing. Wyeth predicts the approval of compounds that are awaiting conclusion of the regulatory action will not be delayed (1"The Pink Sheet" March 5, 2007, p. 17)...

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