Untitled Letter definition

Untitled Letter means an official correspondence sent by the FDA to an individual or firm that is intended to cite regulatory violations that may not meet the threshold of regulatory significance to warrant a Warning Letter or request correction of the violations, and does not include a statement that warns the individual or firm that failure to promptly correct the violation may result in enforcement action.
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Examples of Untitled Letter in a sentence

  • Upon issuance, add a PDF signed copy of the Warning or Untitled Letter into the Final Outcome tab for the action within CMS.

  • If we decide to initiate a regulatory action against a food establishment, we may elect to take an advisory action, such as issuing a Warning Letter, an Untitled Letter, or scheduling a regulatory meeting (Ref.

  • When OCC review of a Warning or Untitled Letter is required: • Send a copy of the draft “final” letter via CMS to OCC for concurrence.

  • When an Untitled Letter is issued as a result of the inspection, the date and type of letter issued should be entered in the Remarks field for the relevant profile classes.

  • Therefore, the format and content of an Untitled Letter should clearly distinguish it from a Warning Letter.

  • Within 45 working days after the receipt of the EIR, the Center will determine if an Untitled Letter is appropriate.

  • Within 45 working days after the receipt of the recommendation, the accompanying documents, and the draft “final” Untitled Letter, the Center should review and approve or nonconcur with the issuance of the letter.

  • If the OPDP determines that a promotion is illegal, it will initiate enforcement by issuing an Untitled Letter, a Warning Letter, or a referral for criminal investigation.

  • Make the decision to issue a Warning Letter or an Untitled Letter.

  • Any Warning or Untitled Letter involving a novel, controversial, or sensitive legal issue.

Related to Untitled Letter

  • Letter means any written or printed communication conveying from one person to another particular information upon matters personal to such persons or information upon which it is intended that the recipient should reply, act or refrain from acting, but does not include any written or printed communication which is a newspaper or a periodical accompanied by any other communication;

  • Facility Letter means the facility letter and the other letters of offer or other letters which may from time to time be issued by the Bank to the Borrower in relation to the Facilities.

  • Acceptance Letter means the letter from Adviser to BD pursuant to which the Adviser appoints BD as a Broker Dealer for each series of MuniPreferred issued by any Fund that has executed a Request Letter.

  • Expiry Date (Data di Scadenza) means the "Expiry Date" as specified in § 1 of the Product and Underlying Data.

  • Facility LC Application is defined in Section 2.19.3.

  • Disbursement Request means a disbursement request from the Borrower to the Administrative Agent and the Collateral Agent in the form attached hereto as Exhibit C in connection with a disbursement request from the Unfunded Exposure Account in accordance with Section 2.04(d) or a disbursement request from the Principal Collection Subaccount in accordance with Section 2.18, as applicable.

  • Contract Modification means any changes in the terms or provisions of the Contract which are reduced to writing and fully executed by both parties.

  • Environmental and Social Commitment Plan or “ESCP” means the environmental and social commitment plan for the Project, dated July 31, 2023, as the same may be amended from time to time in accordance with the provisions thereof, which sets out the material measures and actions that the Recipient shall carry out or cause to be carried out to address the potential environmental and social risks and impacts of the Project, including the timeframes of the actions and measures, institutional, staffing, training, monitoring and reporting arrangements, and any environmental and social instruments to be prepared thereunder.

  • Letter of Credit Reimbursement Agreement has the meaning specified in Section 2.4(e).

  • Commercial use request means a re- quest from or on behalf of one who seeks information for a use or purpose that furthers the commercial, trade, or profit interests of the requester or the person on whose behalf the request is made.

  • improvement notice means the notice issued by the Authority to the Supplier pursuant to Clause 32.1.3 (Authority Remedies) which will detail how the Supplier shall improve the provision of the Goods and/or Services;

  • Approved Lease means (a) each existing Lease as of the Closing Date as set forth in the Leasing Affidavit and (b) each Lease entered into after the Closing Date in accordance with the terms and conditions contained in Section 9.09 as such leases and related documents shall be Modified as permitted pursuant to the terms of this Agreement.

  • Sanction Letter means the letter issued by the Lender sanctioning the Loan with the relevant particulars as mentioned in the letter.

  • Rejected Executory Contract and Unexpired Lease List means the list, as determined by the Debtors or the Reorganized Debtors, as applicable, of Executory Contracts and Unexpired Leases that will be rejected by the Reorganized Debtors pursuant to the Plan, which list shall be included in the Plan Supplement.

  • Objection/Exclusion Deadline means the date by which a written objection to this Settlement Agreement or a request for exclusion submitted by a person within the Settlement Class must be postmarked and/or filed with the Court, which shall be designated as a date approximately forty-two (42) days after the Notice Date, as approved by the Court.

  • Final completion and acceptance means the stage in the progress of the work as determined by the Contracting Officer and confirmed in writing to the Contractor, at which all work required under the contract has been completed in a satisfactory manner, subject to the discovery of defects after final completion, and except for items specifically excluded in the notice of final acceptance.

  • Letter of Offer means any letter, commitment, arrangement or agreement between us and you in relation to the facility. We may revise, add to, vary or replace the letter of offer from time to time.

  • LC Payment Notice has the meaning specified in Section 2.04(e).

  • Auto-Extension Letter of Credit has the meaning specified in Section 2.03(b)(iii).

  • LC Request a request for issuance of a Letter of Credit, to be provided by Borrower Agent to Issuing Bank, in form satisfactory to Agent and Issuing Bank.

  • Letter of Acceptance means the letter of formal acceptance, signed by the contractor. Procuring Entity, including any annexed memoranda comprising agreements between and signed by both Parties.

  • Lender’s Environmental Liability means any and all losses, liabilities, obligations, penalties, claims, litigation, demands, defenses, costs, judgments, suits, proceedings, damages (including consequential damages), disbursements or expenses of any kind or nature whatsoever (including reasonable attorneys’ fees at trial and appellate levels and experts’ fees and disbursements and expenses incurred in investigating, defending against or prosecuting any litigation, claim or proceeding) which may at any time be imposed upon, incurred by or asserted or awarded against the Administrative Agent, any Lender or any Issuer or any of such Person’s Affiliates, shareholders, directors, officers, employees, and agents in connection with or arising from:

  • Post Closing Letter is that certain Post Closing Letter dated as of the Effective Date by and between Collateral Agent and Borrower.

  • Swap Specification means, with respect to any Swap, the Rules or other trading protocols containing specifications for such Swap, as adopted, amended, supplemented or otherwise modified from time to time by BSEF.

  • Commitment Transfer Supplement means a document in the form of Exhibit 16.3 hereto, properly completed and otherwise in form and substance satisfactory to Agent by which the Purchasing Lender purchases and assumes a portion of the obligation of Lenders to make Advances under this Agreement.

  • Commitment means a Term Commitment or a Revolving Credit Commitment, as the context may require.