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FDA Warning Letter Explorer
FDA warning letter · Drugs

Zen Enterprises LLC

Issued · Posted by FDA

FDA published a close-out letter on Sep 17, 2024. The passages below are from the original warning letter.

Selected passages from the FDA letter

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

Passage 1

the manufacturer referenced under the establishment section of the listing SPL files is identified as Dr. Sankunni’s Ayurvedic Research Foundation Private Ltd., (DUNS 650517704). However, in accordance with the response provided on 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 currently involved in the manufacturing of the drugs mentioned above.

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 207.49(a)(12)(i)
  • 21 CFR 207.49(a)(12)(ii)
  • 21 CFR 207.57(b)(2)
  • 21 CFR 207.33(c)
  • 21 CFR 207