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

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

  • The different levels of FDA compliance include: Official Action Indicated (OAI), Voluntary Action Indicated (VAI), and No Action Indicated (NAI).

  • There shall not, with respect to a Group Company, have been an FDA audit that resulted in an OAI (Official Action Indicated).

  • For example, Hospira’s manufacturing facility in McPherson, Kansas is currently under the FDA inspection classification of Official Action Indicated (OAI).

  • In September 2005, the Company learned that the Food and Drug Administration (FDA) had placed it in Official Action Indicated (OAI) status relating to the FDA’s May 2005 current Good Manufacturing Practices (cGMP) inspection of its Davie, Florida manufacturing facility and the related issuance of a Form 483 List of Inspectional Observations.


More Definitions of Official Action Indicated

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

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 (or any equivalent or replacement mechanism).

  • Official traffic-control devices means all signs, signals, markings, and devices not inconsistent with this chapter placed or erected by authority of a public body or official having jurisdiction, for the purpose of regulating, warning, or guiding traffic.

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

  • Commercial sexual activity means sexual activity for which anything of value is given

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

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

  • 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.

  • 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 a New Drug Application as defined in the FFDCA or any corresponding foreign application in the Territory, including, with respect to the European Union, a Marketing Authorization Application filed with the EMA pursuant to the centralized approval procedure or with the applicable Regulatory Authority of a country in Europe with respect to the mutual recognition or any other national approval.

  • 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.

  • 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