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  5. Novel Laboratories, Inc. d.b.a Lupin Somerset - 613385 - 04/14/2023
  1. Warning Letters


Novel Laboratories, Inc. d.b.a Lupin Somerset MARCS-CMS 613385 —

Delivery Method:
UPS Next Day

Recipient Name
Ms. Vinita D. Gupta
Recipient Title
Group President-CEO
Novel Laboratories, Inc. d.b.a Lupin Somerset

B/4 Laxmi Towers
Bandra Kurla Complex, Bandra (E)
Mumbai 400051

Issuing Office:
Office of Pharmaceutical Quality Operations Division I

United States

Dear Ms. Gupta:

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 # 613385], dated June 11, 2021. 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.

Lisa Harlan
Program Division Director
U.S. Food and Drug Administration
OPQO Division I


Mr. Ronald W. Overhiser
Vice President-Operations and Site Head
Novel Laboratories, Inc. d.b.a. Lupin
400 Campus Drive
Somerset, NJ 08873

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