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FDA Warning Letter Explorer
FDA warning letter · Drugs

Ehy Holdings, LLC

Issued · Posted by FDA

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 aforementioned drug listings, the manufacturer referenced is identified as Ehy Holdings, LLC (DUNS 117322715). After review of your June 27, 2023 communication with FDA’s Office of Quality Surveillance (OQS) in the Office of Pharmaceutical Quality (OPQ), it was revealed that Ehy Holdings, LLC is not currently involved in the manufacturing processes of drugs that are being distributed in U.S. commercial distribution nor imported or offered for import into the United States and therefore, should not be registered as a manufacturer. Consequently, the listings for these drug products are not referencing a correct or active registered manufacturing establishment and no listing updates have been provided.

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