What happens after a Form 483 is issued?

The firm typically has 15 business days to submit a written response describing planned corrections. FDA reviews that response, and unresolved or serious findings can lead to a Warning Letter, import alert, or other enforcement action, though many 483s are resolved without further FDA action.

What is the FEI / inspection ID for this Form 483?

FEI / inspection ID: 3013827563.

Is a Form 483 the same as a Warning Letter?

No. A Form 483 lists an FDA investigator’s observations at the close of an inspection; it is not a final agency determination. FDA may or may not follow up with a Warning Letter depending on the firm’s response and the severity of the findings.

Form 483 Record: Catholic Health Initiatives Institute for Research and Innovation IRB, March 3, 2026

Key facts

Firm	Catholic Health Initiatives Institute for Research and Innovation IRB
FEI / inspection ID	3013827563
Inspection end date	March 3, 2026
Citation count	1

In short: FDA inspected Catholic Health Initiatives Institute for Research and Innovation IRB in Colorado, USA and issued a Form 483 listing 1 inspectional observation following an inspection that concluded 2026-03-03. FDA records classify Catholic Health Initiatives Institute for Research and Innovation IRB as a institutional review board. A Form 483 documents an investigator's findings at the close of an inspection under the Federal Food, Drug, and Cosmetic Act; it is not a final agency compliance determination. The observations on this page are drawn directly from the FDA-issued Form 483 record.

Citations explained

Observation 1 — -- 1 of 2 -- The observations of objectionable conditions and practices listed on the

-- 1 of 2 -- The observations of objectionable conditions and practices listed on the front of this form are reported: 1. Pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, or 2. To assist firms inspected in complying with the Acts and regulations enforced by the Food and Drug Administration. Section 704(b) of the Federal Food, Drug, and Cosmetic Act (21 USC 374(b)) provides: "Upon completion of any such inspection of a factory, warehouse, consulting laboratory, or other establishment, and prior to leaving the premises, the officer or employee making the inspection shall give to the owner, operator, or agent in charge a report in writing setting forth any conditions or practices observed by him which, in his judgment, indicate that any food, drug, device, or cosmetic in such establishment (1) consists in whole or in part of any filthy, putrid, or decomposed substance, or (2) has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. A copy of such report shall be sent promptly to the Secretary." -- 2 of 2 -- A Form FDA 483 is issued at the close of an FDA facility inspection to list conditions an investigator observed that may violate the Federal Food, Drug, and Cosmetic Act or its implementing regulations. It reflects the investigator's professional judgment at that point in time and is not a final agency determination, an enforcement action, or proof that a violation occurred. Firms are expected to respond in writing, typically within 15 business days, describing the corrective and preventive actions they plan to take. FDA reviews that response, along with any follow-up evidence, before deciding what happens next. Many 483s are resolved through corrective action alone. When FDA judges a firm's response inadequate, or when the underlying conditions are serious enough, the observations documented here can lead to a Warning Letter or further regulatory action. This page presents the observations exactly as recorded on the FDA-issued document; always confirm citation language against the original record before relying on it.

What a Form 483 means

A Form FDA 483 is issued at the close of an FDA facility inspection to list conditions an investigator observed that may violate the Federal Food, Drug, and Cosmetic Act or its implementing regulations. It reflects the investigator's professional judgment at that point in time and is not a final agency determination, an enforcement action, or proof that a violation occurred. Firms are expected to respond in writing, typically within 15 business days, describing the corrective and preventive actions they plan to take. FDA reviews that response, along with any follow-up evidence, before deciding what happens next. Many 483s are resolved through corrective action alone. When FDA judges a firm's response inadequate, or when the underlying conditions are serious enough, the observations documented here can lead to a Warning Letter or further regulatory action. This page presents the observations exactly as recorded on the FDA-issued document; always confirm citation language against the original record before relying on it.

Catholic Health Initiatives Institute for Research and Innovation IRB’s FDA history

Argus HQ has recorded 1 total FDA action tied to Catholic Health Initiatives Institute for Research and Innovation IRB: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.

Frequently asked questions

What happens after a Form 483 is issued?: The firm typically has 15 business days to submit a written response describing planned corrections. FDA reviews that response, and unresolved or serious findings can lead to a Warning Letter, import alert, or other enforcement action, though many 483s are resolved without further FDA action.
Has Catholic Health Initiatives Institute for Research and Innovation IRB had other FDA inspection citations?: This is the only FDA action Argus HQ has on file for Catholic Health Initiatives Institute for Research and Innovation IRB so far. Argus ingests new FDA records daily.
What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3013827563.
Is a Form 483 the same as a Warning Letter?: No. A Form 483 lists an FDA investigator’s observations at the close of an inspection; it is not a final agency determination. FDA may or may not follow up with a Warning Letter depending on the firm’s response and the severity of the findings.

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Full FDA history for Catholic Health Initiatives Institute for Research and Innovation IRB

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Form 483 Record: Catholic Health Initiatives Institute for Research and Innovation IRB, March 3, 2026 — 1 Citations. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/483/catholic-health-initiatives-institute-for-research-and-innovation-irb-3013827563-2026-03-03

MLA

"Form 483 Record: Catholic Health Initiatives Institute for Research and Innovation IRB, March 3, 2026 — 1 Citations." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/483/catholic-health-initiatives-institute-for-research-and-innovation-irb-3013827563-2026-03-03.

Chicago

Argus HQ Research. "Form 483 Record: Catholic Health Initiatives Institute for Research and Innovation IRB, March 3, 2026 — 1 Citations." Digital Empire Holdings LLC. Accessed August 17, 2026. https://argushq.ai/483/catholic-health-initiatives-institute-for-research-and-innovation-irb-3013827563-2026-03-03.

BibTeX

@misc{argushq_argushq_ai_483_catholic_health_initiatives_institute_for_research_and_innovation_irb_3013827563_2026_03_03_2026,
  title = {Form 483 Record: Catholic Health Initiatives Institute for Research and Innovation IRB, March 3, 2026 — 1 Citations},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/483/catholic-health-initiatives-institute-for-research-and-innovation-irb-3013827563-2026-03-03},
  note = {Accessed: August 17, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗