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Division of Teva Pharmaceutical Industries Ltd.

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Recent Dealmaking (9/2003)

Summarizing the month in European dealmaking.


...issued to foreign drug manufacturers in FY 1997 dropped by two-thirds from the previous year. The inspection performance declined for domestic firms, which received 50% more agency warnings than in FY 1996. Warning letters to oral solid manufacturers correspond with recall actions during FY 1997. Failure investigations, stability programs, and process validation remain key FDA compliance concerns. HPLC testing and labeling/ packaging procedures are also on the agency’s radar screen. [The drug cGMP warning letters issued in FY 1997 are listed on pp. 8-16. The listing includes the recipient's name, letter date, plant location and a description of the problem areas cited.


DRUG RECALL DATA FOR 1997 a resurgence in recalls related to application integrity issues. Potency problems continue to be the source of a high percentage of recalls. Overall, the number and types of drug product recalls reported in 1997 are in line with the 1996 tally. Labeling/packaging recalls are an exception, more than doubling from the prior year. Comments on a proposed cGMP rule modifying the cut labeling provisions are under review at FDA. Recalls of injectables also spike in 1997. FDA considers four drug recalls involving various dosage forms and one therapeutic biological recall dangerous enough to warrant a Class I rating. [A nine-page tabulation of recalls listed in FDA "Enforcement Reports" during 1997 is included.]

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  • Robert Gunter, Pres.
    James Moore, Dir., Fin.
    Sidney Baron, SVP, Sales & Mktg.
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