CLOSEOUT LETTER
Nephron SC, LLC MARCS-CMS 634647 —
- Reference #:
- FEI 3010892830
- Product:
- Drugs
- Recipient:
-
Recipient NameMs. Lou W. Kennedy
-
Recipient TitleChief Executive Officer
- Nephron SC, LLC
4500 12th Street Ext.
West Columbia, SC 29172
United States
- Issuing Office:
- Office of Pharmaceutical Quality Operations, Division II
United States
United States
Dear Ms. Kennedy:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter Case # 634647 dated October 11, 2022.
Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and 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 assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority.
The FDA expects you and your firm to maintain compliance and will 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/
Michael Klapal
Consumer Safety Officer
Office of Manufacturing Quality