Dr Sankunni’s Ayurvedic Research Foundation Private Ltd.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

In the listing files submitted to FDA for the previously mentioned drugs, the manufacturer referenced is identified as Dr. Sankunni’s Ayurvedic Research Foundation Private Ltd., (DUNS 650517704). However, in accordance with the response provided December 15, 2022, to the Office of Quality Surveillance (OQS) in the Office of Pharmaceutical Quality (OPQ) to their 704(a)(4) records request, it was confirmed that Dr. Sankunni’s Ayurvedic Research Foundation Private Ltd. is not involved in manufacturing of the drugs mentioned above, and therefore, this firm should not be registered with FDA as a manufacturer.

Passage 2

On March 6, 2023, OQS/OPQ requested that Dr. Sankunni’s Ayurvedic Research Foundation Private Ltd. deregister their establishment and delist all drug listings which reference Dr. Sankunni’s Ayurvedic Research Foundation Private Ltd. as the manufacturer. However, to date, no updates have been made to the listing files to correct the manufacturer’s name and the firm remains registered as a manufacturer.

Passage 3

Mismatched strength of menthol in the listing SPL.

Passage 4

The labeling also includes a carton label image of another product which is not listed.

Passage 5

There is a mismatched dosage form between the labeling and the listing SPL.

Passage 6

The listing SPL does not include the active ingredient methyl salicylate which is found in the labeling.