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
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Official Action Indicated. (or “OAI” or similar classification), or resulted in enforcement actions by any international Government Entity.
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Official Action Indicated. (OAI), “which means regulatory and/or administrative actions will be recommended.” (Am. Compl. ¶ 53.)
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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.

  • The EIR is examined by officials at a District Office of the FDA who determine whether the facility meets the criteria for No Action Indicated (“NAI”), Voluntary Action Indicated (“VAI”), or Official Action Indicated (“OAI”).

  • 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.

  • Commander Emerson testified that, as a result of this investigation, she recommended “OAI” [Official Action Indicated] “[b]ecause of the seriousness of the problems we identified ….

  • When a notification is issued under this subparagraph, FDA will terminate any import alert associated with the facility that is the subject of the notification and remove that facility from Official Action Indicated status, and Defendants may introduce into interstate commerce any FDA-approved drugs manufactured at such facility after the date of such notification.

  • The officers of the Corporation shall consist of a Chairman (revised 9-13), President, Vice-President, Secretary, and Treasurer, each of whom shall be elected by the Board.

  • 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.

  • 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.

  • 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).


More Definitions of Official Action Indicated

Official Action Indicated. , means approvals of pending applications orsup- plements from this site maybe withheld.
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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.
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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.
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Related to Official Action Indicated

  • Attack directed against any civilian population means a course of conduct involving the multiple commission of acts referred to in paragraph 1 against any civilian population, pursuant to or in furtherance of a State or organizational policy to commit such attack;

  • 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 an Abbreviated New Drug Application filed with the FDA pursuant to its rules and regulations.

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

  • Commercial sexual activity means any sex act on account of which anything of value is given to, promised to, or received by any person.

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

  • Commercial applicator means any person, unless exempted in I(4) hereunder, whether or not the person is a private applicator with respect to some uses, who:

  • Third Party Infringement Claim has the meaning set forth in Section 5.4.

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • 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 or use of a Product as a drug in a regulatory jurisdiction.

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

  • Anti-Static Product means a product that is labeled to eliminate, prevent, or inhibit the accumulation of static electricity. “Anti-Static Product” does not include “Electronic Cleaner,” “Floor Polish or Wax,” “Floor Coating,” and products that meet the definition of “Aerosol Coating Product” or “Architectural Coating.”

  • 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