Official Action Indicated definition

Official Action Indicated. , means approvals of pending applications or supplements from this site maybe withheld. The USFDA has stated that this facility may be subject to regulatory or administrative action and that it may withhold approval of any pending appli- cations or supplements in which this facility is listed, the
Official Action Indicated. (OAI), “which means regulatory and/or administrative actions will be recommended.” (Am. Compl. ¶ 53.)
Official Action Indicated. (or “OAI” or similar classification), or resulted in enforcement actions by any international Government Entity.

Examples of Official Action Indicated in a sentence

  • Specifically, we implemented a process to notify facilities of final facility inspection classifications (i.e., No Action Indicated, Voluntary Action Indicated, or Official Action Indicated) within 90 days from the close of the inspection.

  • Inspections conducted in the last five years have led to two No Action Indicated (NAI) classifications, and two Official Action Indicated (OAI) classifications--one warning letter and one untitled letter.

  • The Company’s Active Pharmaceuticals Ingredients (‘API’) plant at Nanjangud was under Official Action Indicated (‘OAI’) classification from the USFDA.

  • Inspections will be classified Official Action Indicated, OAI, whenever a Warning Letter is issued.

  • Inspections will be classified Official Action Indicated (OAI) whenever a Warning Letter is issued.

  • Level 3 inspections are necessary after a firm is found to have Situation I conditions during a previous QS inspection which was classified Official Action Indicated (OAI).

  • Inspections can be classified as Official Action Indicated (OAI), Voluntary Action Indicated (VAI), or No Action Indicated (NAI).

  • Compliance ClassificationsNAI = No Action Indicated, no deviation from regulations.VAI = Voluntary Action Indicated, deviation(s) from regulations.OAI = Official Action Indicated, significant deviations from regulations.

  • A finding of Official Action Indicated indicates that some type of corrective action would be required before FDA would approve the ANDA.

  • There shall not, with respect to Parent or its Subsidiaries, have been an FDA audit that resulted in an OAI (Official Action Indicated).


More Definitions of Official Action Indicated

Official Action Indicated or "OAI" means a farm inspection classification that indicates one or more egregious violations materially related to food safety have been cited, or that an uncorrected VAI condition on a previous inspection has been cited.
Official Action Indicated or "OAI" means a plant inspection classification that indicates a condition noted during the inspection was significant enough to pose an imminent health hazard or was an uncorrected VAI condition on a previous inspection.
Official Action Indicated. , means approvals of pending applications orsup- plements from this site maybe withheld.

Related to Official Action Indicated

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  • Commercial activity means any activity or employment of the vessel for which a contract or charter party is in force and includes the carriage of any cargo or persons for reward;

  • ANDA means Abbreviated New Drug Application.

  • Victim or target of Nazi persecution means any individual persecuted or targeted for persecution by

  • Commercial sexual activity means any sex act or sexually explicit performance for which anything of value is given, promised to, or received by any person and includes, but is not limited to, prostitution, participation in the production of pornography, and performance in strip clubs.

  • Free Trade Agreement country end product means an article that—

  • Commercial applicator means a person who, by contract or for hire, engages in the

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

  • Third Party Infringement Claim has the meaning set forth in Section 23.5.1.

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

  • Third Party IP Claim has the meaning given to it in clause E8.7 (Intellectual Property Rights).

  • Therapeutic interchange means an authorized exchange of therapeutic alternate drug products in accordance with a previously established and approved written protocol.

  • commercial air transport means an aircraft operation involving the transport of passengers, cargo, or mail for remuneration or hire.

  • Therapeutic court personnel means the staff of a mental

  • Intimidating, threatening, abusive, or harming conduct means, but is not limited to, conduct that does the following:

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.

  • Third Party Infringement has the meaning set forth in Section 5.1.

  • Collaborative pharmacy practice agreement means a written and signed

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale of a Product as a pharmaceutical product in a regulatory jurisdiction.

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • Order and Final Judgment means the order and final judgment of the Court approving the Settlement Agreement, as described in Section II(E)(7) below.

  • Product Infringement has the meaning set forth in Section 9.4(a).

  • Number of Students Who Began the Program means the number of students who began a program who were scheduled to complete the program within 100% of the published program length within the reporting calendar year and excludes all students who cancelled during the cancellation period.

  • Juvenile court means the district court of this state.

  • low protein modified food product means a food product that is specially formulated to have less than one gram of protein per serving and is intended to be used under the direction of a Practitioner for the dietary treatment of an inherited metabolic disease, but does not include a natural food that is naturally low in protein; and