FDA warning letter · File paradigm-peptides · Storefront checked
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Paradigm Peptides: FDA warning letter dated
paradigmpeptides.com · recipient as the record gives it: Paradigm R.E. LLC · storefront at check: Closed
What the record says
What the letter concerned
The record says the letter concerned one product named in the letter, marketed with COVID-19 claims and described by the agency as an unapproved new drug and misbranded.
The storefront has since closed. The file records a later guilty plea and sentence for the owner, from Department of Justice and news sources, on matters separate from the letter.
The letter is dated and is addressed, as the record gives it, to Paradigm R.E. LLC. We record the date printed on the letter and the address of the agency's page; we do not reproduce the agency's text, and we do not record whether the company replied. On the storefront at paradigmpeptides.com was recorded as closed.
Facts on file
The letter, line by line
Date printed on the letter
Recipient, as the record gives it
Paradigm R.E. LLC
Products named
one product, described on this desk only as GLP-class products or products named in the letter
Response deadline
Not recorded in the file; the letter on fda.gov states it
Company response
Not recorded in the file; posted by the agency on the same page when received
Is Paradigm Peptides still in business after the FDA warning letter?
No. The storefront is recorded as closed; the file and the shutdowns registry hold what the record says about the closure. The letter dated 2020-12-07 predates it.
Did Paradigm Peptides respond to the FDA?
The file does not record a response. When the agency posts a company's reply or a close-out letter it does so on the same fda.gov page the letter sits on, which is linked from this page; the desk does not paraphrase either.
What does the letter do to the file?
The "no FDA warning letter on record" check is stamped Not verified and the seal is held at C or below for as long as the letter stands in the public record. The other seven checks are read as usual.
What a warning letter is and is not, in general terms, is set out in What an FDA warning letter actually says; the research-use question in Research-use-only labeling explained. The file was read on ; corrections to editors@peptidetruth.org. Paradigm Peptides sells, or sold, material labeled for laboratory research use only; this page concerns a public document about the company, nothing else.
