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Samples in periodicals archive:
However, for the second year in a row, FDA noted in recent information presented on tissue inspections that reproductive establishments still had the highest percentage of inspections rated with an Official Action Indicated (OIA), meaning that objectionable conditions were found that warrant action.
Food and Drug Administration ("FDA") has completed the inspection of the company's Florida manufacturing facilities and has informed the Company that it has removed the Official Action Indicated ("OAI") status at Watson's Davie, Florida site.
In 2008, the Davie, FL facility was removed from Official Action Indicated (OAI) status, which had been in place since 2005.
Fitch will monitor the company's efforts toward lifting the Official Action Indicated (OAI) status placed on the Davie, FL, facility by the FDA in September 2005, effectively placing a hold on all pending product approvals, generic Toprol, and the ActosPlus branded pharmaceutical.
The approval and launch of Andrx's ANDAs for the 25mg, 50mg, 100mg and 200mg strengths of its metoprolol succinate extended-release tablets are subject to, among other things, the Food and Drug Administration's (FDA) removal of Andrx's Official Action Indicated (OAI) status, satisfying all other FDA approval requirements, successful validation and potential future legal proceedings by Astra.