CLOSEOUT LETTER
Indus Medicare Limited MARCS-CMS 606159 —
- Product:
- Medical Devices
- Recipient:
-
Recipient NamePingle Janardhan Reddy
-
Recipient TitleManaging Director
- Indus Medicare Limited
Sy No. 129, NH-44, Ramaipally Village
Manoharabad Mandal
Medak District 502336
Telangana
India
- Issuing Office:
- Center for Devices and Radiological Health
United States
Dear Pingle Janardhan Reddy:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS #606159, dated May 4, 2020). Based on our evaluation, it appears that you have addressed the violation(s) 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 Agency 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 yours,
/S/
Sharon M. Andrews
Director
DHT3B: Division of Reproductive,
Gynecology and Urology Devices
OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
CC:
Bill Taffs
Eagle TWE Inc.,
4761 Hugh Howell Road, Unit M
Tucker, Georgia 30084
Email: Bill@Eagletwe.com