Does this Form 483 mean Denver Solutions LLC dba Leiters Health violated the law?

No. A Form 483 documents an investigator's observations only. FDA reviews the firm's written response and any corrective actions taken before deciding whether further action is warranted, and many 483s are closed without additional enforcement once a firm shows adequate correction.

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 Denver Solutions LLC dba Leiters Health had other FDA inspection citations?

This is the only FDA action Argus HQ has on file for Denver Solutions LLC dba Leiters Health so far. Argus ingests new FDA records daily.

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

FEI / inspection ID: 3013438582.

FDA Form 483 — Denver Solutions LLC dba Leiters Health (June 8, 2026)

Key facts

Firm	Denver Solutions LLC dba Leiters Health
FEI / inspection ID	3013438582
Inspection end date	June 8, 2026
Citation count	1

Key takeaway: FDA inspected Denver Solutions LLC dba Leiters Health in Colorado and issued a Form 483 listing 1 inspectional observation following an inspection that concluded 2026-06-08. FDA records classify Denver Solutions LLC dba Leiters Health as a outsourcing facility. 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.

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.

Citations explained

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,.-... ( ~ lfflll U.S. FOOD & DRUG ~,...~ ~l- - ADMINISTRATION VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED June 8, 2026 Stephan Paul Granberry President and Chief Executive Officer Denver Solutions, LLC dba Leiters Health 13796 Compark Blvd. Englewood, CO 80112-7145 Dear Mr. Granberry: You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 353b]1 on March 24, 2017, and most recently on November 28, 2025. From November 13, 2025, to December 11, 2025, an FDA investigator inspected your facility, Denver Solutions, LLC dba Leiters Health, located at 13796 Compark Blvd., Englewood, CO 80112. During the inspection, the investigator noted deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk. FDA issued a Form FDA 483 to your facility on December 11, 2025. We reviewed your January 8, 2026, February 13, 2026, and March 13, 2026, responses to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. Based on this inspection, it appears you produced drugs tha 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.

Denver Solutions LLC dba Leiters Health’s FDA history

Argus HQ has recorded 1 total FDA action tied to Denver Solutions LLC dba Leiters Health: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.

Frequently asked questions

Does this Form 483 mean Denver Solutions LLC dba Leiters Health violated the law?: No. A Form 483 documents an investigator's observations only. FDA reviews the firm's written response and any corrective actions taken before deciding whether further action is warranted, and many 483s are closed without additional enforcement once a firm shows adequate correction.
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 Denver Solutions LLC dba Leiters Health had other FDA inspection citations?: This is the only FDA action Argus HQ has on file for Denver Solutions LLC dba Leiters Health so far. Argus ingests new FDA records daily.
What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3013438582.

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Full FDA history for Denver Solutions LLC dba Leiters Health

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). FDA Form 483 — Denver Solutions LLC dba Leiters Health (June 8, 2026) — 1 Citations. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/483/denver-solutions-dba-leiters-health-3013438582-2026-06-08

MLA

"FDA Form 483 — Denver Solutions LLC dba Leiters Health (June 8, 2026) — 1 Citations." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/483/denver-solutions-dba-leiters-health-3013438582-2026-06-08.

Chicago

Argus HQ Research. "FDA Form 483 — Denver Solutions LLC dba Leiters Health (June 8, 2026) — 1 Citations." Digital Empire Holdings LLC. Accessed July 29, 2026. https://argushq.ai/483/denver-solutions-dba-leiters-health-3013438582-2026-06-08.

BibTeX

@misc{argushq_argushq_ai_483_denver_solutions_dba_leiters_health_3013438582_2026_06_08_2026,
  title = {FDA Form 483 — Denver Solutions LLC dba Leiters Health (June 8, 2026) — 1 Citations},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/483/denver-solutions-dba-leiters-health-3013438582-2026-06-08},
  note = {Accessed: July 29, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗