FDA-Inspected Site

Denver Solutions, LLC

5 FDA inspections are on record for Denver Solutions, LLC in Englewood, United States.

483· Form 483 issued

Englewood, United States · Last updated July 10, 2026

Overview

  • 5 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-12-11.

At a glance

Inspections

5

Form 483s

5

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
13 Nov 2025 – 11 Dec 2025Human Drugs483View 483 →
20 Mar 2024 – 5 Apr 2024Human Drugs483View 483 →
23 Sep 2021 – 7 Oct 2021Human Drugs483View 483 →
1 Jul 2019 – 18 Jul 2019Human Drugs483View 483 →
12 Feb 2018 – 23 Feb 2018Human Drugs483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

11 Dec 2025
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Margaret M Annes

11 Dec 2025
21 CFR 211.110(a)

Written in-process control procedures

Cited by Margaret M Annes

11 Dec 2025
21 CFR 211.113(b)

Validation lacking for sterile drug products

Cited by Margaret M Annes

11 Dec 2025
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Margaret M Annes

11 Dec 2025
21 CFR 211.42(c)(10)(iv)

Environmental Monitoring System

Cited by Margaret M Annes

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations3x
21 CFR 211.192Cited across public-safe Form 483 observations3x
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations3x
21 CFR 211.160(b)Cited across public-safe Form 483 observations2x
21 CFR 211.42(c)(10)(v)Cited across public-safe Form 483 observations2x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.165(f)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(i)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(iii)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
FDCA 503B(a)(10)(A)Cited across public-safe Form 483 observations1x
FDCA 503B(a)(10)(B)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Denver Solutions, LLC's 5 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat