U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Rite Aid Corporation - 643207 - 12/20/2022
  1. Warning Letters

CLOSEOUT LETTER

Rite Aid Corporation MARCS-CMS 643207 —

Reference #:
WL 2277
Product:
Drugs

Recipient:
Recipient Name
Elizabeth Hanlon
Rite Aid Corporation

200 Newberry Commons
Etters, PA 17319
United States

Issuing Office:
Center for Drug Evaluation and Research | CDER

United States


Dear Ms. Hanlon:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 2277. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter and corrected the data deficiencies. We have received an updated listing SPL with the correct list of active ingredients and an updated labeler code request SPL with the updated contact information. Future FDA regulatory activities will further assess the adequacy and sustainability of these corrections. 

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and to continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. 


Sincerely,
/S/
Carolyn E. Becker, JD
Director, Office of Unapproved Drugs & Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research U.S. Food and Drug Administration

Back to Top