Key facts
| Firm | Denver Solutions, LLC |
|---|---|
| FEI / inspection ID | 3013438582 |
| Inspection end date | December 11, 2025 |
| Citation count | 7 |
Citations explained
Observation 1 — Your firm failed to establish adequate written procedures for production and process
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess. The aseptic filling process for Bevacizumab 25 mg / ml injection has not been adequately validated. Specifically, the initial process validation was performed using ::::!=::!~----' test method that your firm later determined was incapable of detecting the ._......._.__ _, particulates that are a known contaminant in your process. Furthermore, after making significant changes to the process-including the introduction of a new test method and the implementation of a critical ..............--__, ..............L.I step per SOP-0200 Avastin Processing Procedure - you failed to perform a complete re-validation of the manufacturing process to demonstrate that it can consistently produce product meeting all specifications. Since identifying ._......_,.~ contamination from your filling equipment, you have relied on - as a routine manufacturing step to bring failing product ba ck into.
Observation 2 — Equipment used in the manufacture, processing, packing or holding of drug products
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use. Equipment used in the aseptic filling of Bevacizumab 25 mg / ml for intravitreal injection is not of appropriate design to prevent product contamination. Specifically, your firm uses , as a product-contact component .._......___ _, of you ..,_.1,,11,,,,--.., Your investigation into Deviation ~~-----. and a notebook study performed by your firm , confirmed that this leache ._._.__ __, into the product, which is one of the main root causes of recurring Out-of-Specification (OOS) results for subvisible particulates. Despite this, you continue to use this component. The selection of this was not supported by initial qualification studies to ensure its suitability for use with a biologic product for ophthalmic use.
Observation 3 — Aseptic processing areas are deficient regarding the system for monitoring environmental conditions
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Observation 4 — Written procedures are not established that describe the in-process controls, tests and
Written procedures are not established that describe the in-process controls, tests and examinations to be conducted on appropriate samples of in-process materials of each batch. Specifically, your firm has no documented justification for the sample size of --~~matter the batch size or the extraction of only .,_._.a...a- of solution from each of the ..,_.a..a..,,L-.1 containers to perform the supplemental visual inspection of drug products where the drug products and /or the container closure system permits limited visual inspection of the contents. For example, your firm fills Ropivacaine HCI 0.2% into opaque On-Q pumps (545ml and 745ml fills). Lot sizes since April 1, 2024 have ranged from ._._.,_....__, pumps lots and sublets).
Observation 5 — EMPLOYEE(S) SIGNATURE DATE ISSUED SEE REVERSE Margare t M Annes, cso 1
EMPLOYEE(S) SIGNATURE DATE ISSUED SEE REVERSE Margare t M Annes, cso 1 2/ 11 /2025 OF THIS PAGE PAGE 4 of6 PAGES
Observation 6 — Aseptic processing areas are deficient regarding the system for cleaning and disinfecting
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. Specifically, a) Disinfectant efficacy studies do not include all material from all critical areas where sterile drugs are made. For example, • The studies failed to include the use of ________ ) on any surface except fo -~ gloves. ._......_....__-=-__, is used on surfaces in ISO cleanrooms/areas including equipment and laminar flow hoods. • The studies failed to include the use of .,_.i..a.;,;.,_________ __, on all surfaces in the IS~ IS areas for the automated syringe filler including the gloves and panels of the ..............&..._____________ __, • The studies failed to include the materials that comprise the floors , walls and ceilings of the IS ctl and ISctl cleanrooms.
Observation 7 — Laboratory controls do not include the establishment of scientifically sound and appropriate
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components, in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity. Specifically, a) Your firm is taping shut media plates used for environmental and personnel monitoring (completely wrapping the plate closure) which may result in a low-oxygen environment inside the plates, which in turn could compromise the growth/recovery of aerobic microorganisms. b) Your firm is not adequately preparing product samples for endotoxin testing. For example, your firm is not vortexing the product sample before removing the test portion for endotoxin testing. *DATES OF INSPECTION 11/13/2025(Thu), 11/14/2025(Fri), 11/17/2025(Mon), 11/18/2025(Tue), 12/11/2025(Thu) SEE REVERSE OF THIS PAGE
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.
Denver Solutions, LLC’s FDA history
Argus HQ has recorded 1 total FDA action tied to Denver Solutions, LLC: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- 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.
- Where can I read the full Form 483?
- The verbatim inspection record is the source of truth — always confirm citation language against the original FDA document before acting.
- What is an FDA Form 483?
- A Form FDA 483 lists an FDA investigator's written observations at the close of a facility inspection, issued under section 704(b) of the Federal Food, Drug, and Cosmetic Act. It documents conditions the investigator judged may violate FDA regulations. A 483 is not an enforcement action or a final determination that a violation occurred.
- Does this Form 483 mean Denver Solutions, LLC 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.
See if this 483 escalates to a warning letter — before your auditor asks.
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Related enforcement actions
Full FDA history for Denver Solutions, LLCCompiled 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.
Argus HQ Research (2025). Denver Solutions, LLC — FDA Form 483 Inspection, December 11, 2025 (7 Citations). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-denver-solutions-llc-2025-12-11-3013438582
"Denver Solutions, LLC — FDA Form 483 Inspection, December 11, 2025 (7 Citations)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-denver-solutions-llc-2025-12-11-3013438582.
Argus HQ Research. "Denver Solutions, LLC — FDA Form 483 Inspection, December 11, 2025 (7 Citations)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-denver-solutions-llc-2025-12-11-3013438582.
@misc{argushq_argushq_ai_483_fda_483_denver_solutions_llc_2025_12_11_3013438582_2025,
title = {Denver Solutions, LLC — FDA Form 483 Inspection, December 11, 2025 (7 Citations)},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-denver-solutions-llc-2025-12-11-3013438582},
note = {Accessed: July 13, 2026}
}