Gulf States International, Inc.
1 extracted findings · 1 model-assigned issue type
FDA source excerpt, selected passage
On September 9, 2022, the FDA sent an electronic request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 374(a)(4), to the contact e-mail address provided in your registration file. This request went unanswered, as did another email…
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
The firm failed to respond to FDA's records requests under section 704(a)(4), constituting a refusal to permit access to or copying of records as required, which is a prohibited act under section 301(e).
Supporting FDA text
Source excerpt · automated text-match checkOn September 9, 2022, the FDA sent an electronic request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 374(a)(4), to the contact e-mail address provided in your registration file. This request went unanswered, as did another email request sent on September 27, 2022. On October 3, 2022, you sent an email acknowledging FDA’s request, but did not respond to the 704(a)(4) request. FDA attempted to contact you by phone on November 16, 2022, and left a voicemail requesting that you provide a response by October 31, 2022. FDA also attempted to contact you by phone on September 6, 2023, and left a voicemail with your firm requesting a response within 24 hours. You failed to respond to these attempted communications or otherwise provide the requested records or other information.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
Source passage selected by the model
What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- Provide records and other information pursuant to section 704(a)(4) of the FD&C Act, as requested in the FDA's electronic request sent on September 9, 2022, and subsequent follow-up communications.
- Confirm or update your registration and/or drug listing status.
- Indicate whether you will respond to the request for records and other information.