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  5. LNK International, Inc. - 582253 - 12/01/2021
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CLOSEOUT LETTER

LNK International, Inc. MARCS-CMS 582253 —

Delivery Method:
READ/DELIVERY RECEIPT
Product:
Drugs
Recipient:
Recipient Name
Mr. Pankaj S. Chudgar
Recipient Title
President
LNK International, Inc.

22 Arkay Dr
Hauppauge, NY 11788
United States

Issuing Office:
Division of Pharmaceutical Quality Operations I

United States

Dear Mr. Chudgar:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [CMS #582253], dated September 26, 2019. Based on our evaluation, it appears that you have adequately addressed the violations contained in this Warning Letter.

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.

Respectfully,
/S/
Diana Amador-Toro
Program Division Director/District Director
U.S. Food and Drug Administration
OPQO Division I / New Jersey District

 
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