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 Qualgen LLC had other FDA inspection citations?

This is the only FDA action Argus HQ has on file for Qualgen LLC so far. Argus ingests new FDA records daily.

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

FEI / inspection ID: 3011286349.

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.

September 4, 2025 FDA Form 483 for Qualgen LLC

Key facts

Firm	Qualgen LLC
FEI / inspection ID	3011286349
Inspection end date	September 4, 2025
Citation count	5

The short version: FDA inspected Qualgen LLC in Oklahoma and issued a Form 483 listing 5 inspectional observations following an inspection that concluded 2025-09-04. FDA records classify Qualgen LLC 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

Observation 1 — There is ins ufficient physical or spatial separation from operations and other

There is ins ufficient physical or spatial separation from operations and other mug products to prevent mix-ups and cross-contamination. Specifically, Hazardous mugs were produced without appropriate con tainment, separation, and cleaning to prevent cross-contamination. A) The t1>rf<lr ISO O production rooms where testosterone and estradiol implantable pellets are manufactured are positive pressure to the shared ISO D ante room where employees don and do ff gowning and PPE. The shared Isc{1 ante room is not clean ed between production of testosterone and estradiol m11g products in the aojoining ISO production room s. B) Your fnm does not l} ave documentation to demonstrate that the(D) (~ ) Iand (b) <4lcleaning agents used during (1:> )14 cleaning of the ISO □ produ ct i o n rooms and ISO D ante and prep rooms are e ffective fo r deactivation of hazardous mug residues such as testosterone and estradio l. Additionally, your fnm has not evaluated the e ffectiveness of your cleaning.

Observation 2 — The responsibilities and procedures applicable to the quality control unit are not

The responsibilities and procedures applicable to the quality control unit are not in writing and fully fo llowed. ***REPEAT OBSERVATION FROM INSPECTION CONDUCTED 2/6/2024 - 3/19/2024*** Specifica lly, A) Your procedure to document cleaning of [(6 ) (,4) I Units is not fully fo llowed. Your fom ' s procedure QG -11 83, '\(b) (4 ~ Cleanin~and Storage" effective 1/ 13 /2025, states that pre-use and post-use cleaning of the:~~ t> ) (4 ) units by production employees should be documented and veri fi ed in your film 's (b) (4 \ Cleaning Logs, ELB- 2025-009, at the time of completion of each cleaning activity. Video recording of production operations conducted on 8/ 11 /2025 show production employees conduct the pre-cleaning anq post cleaning of the!(t5 ) (4 ~ units but does not provide evidence to demonstrate that th efl:5) (4 i cleaning was documented at the time of completion. Production employees verified the ~t> ) (4 )J Cleaning Logs.

Observation 3 — The quality control unit lacks responsibility to reject all procedures or specifications

The quality control unit lacks responsibility to reject all procedures or specifications impacting on the identity, strength, quality and purity of diug products. Specifically, EM PLOYE E($) SIGNATURE DATE lSSUEO SEE REVERSE Logan T Williams, Investigator 9/4/2025 THIS PAGE X .. ,__,,_,,,, OF Zachary L Stamm, Investigator a;,aeo~L'CHl'IRYLST~ Oillll-8l,)'le«09<14-3l2S -, sm:11

Observation 4 — Procedures designed to prevent microbiological contamination of diug products pmp o1iing to

Procedures designed to prevent microbiological contamination of diug products pmp o1iing to be sterile are not estab li shed, written and fo ll owed. ***REPEAT OBSERVATION FROM INSPECTION CONDUCTED 2/6/2024 - 3/ 19/2024*** Speci fi ca lly, Your fnm's reva li da tion of{6) (4) I t asset during steri li zation of stoppers, OCD) (~)J 6 ~ ) <4 per fo1med on 5/1/2025, utilized in the container closure of vialed pellets did not meet the maximum load or time fo r the cycle used in production. Your fnm's production oven cycle is ~D) (4 ))ijr (6) (4) I stopp lers acrossu rays an~(t5) (~ ))shelves. The validated cycle is [(b (4 )]o (b) (4) stoppers across O trays and K6) (4 )]shelves. In addition, your fnm does not have load patterns documented in any procedure, work instruction, or ti·a ining material for new operators. The load pattern for stoppers is also not included in the revalidation protocol. Cycle parameters.

Observation 5 — Laborato1y contro ls do not include the establishment of scientifically sound and

Laborato1y contro ls do not include the establishment of scientifically sound and appropriate specifications and sampling plans designed to assure that dmg products confo1m to appropriate stan dards of identity, strength, qua li ty and puri ty. Specifica lly, A) Your fnm 's environmenta l monitoring alert and action limits are not scienti fi cally justifi ed. Your fnm 's procedure fo r environmenta l monitoring, QG -1 218, "Environmental Monitoring" effective 07/ 03 /2025, states that the personnel finge1iip samp le ale1i and action levels in 1so{j are ~2 CFU and ~5 CFU, respectively. Your fnm's Director of Qua li ty stated that these limits were taken fr om USP <1116> and USP <797>, however, yo ur fnm has not evaluated the suitability of those levels within your operations. For exampl e, your fnm recovered mold during personnel finge1iip sampling but did not investigate or identify the recovered organism to the species level based on the action level. Estra.

Qualgen LLC’s FDA history

Argus HQ has recorded 1 total FDA action tied to Qualgen LLC: 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 Qualgen LLC had other FDA inspection citations?: This is the only FDA action Argus HQ has on file for Qualgen LLC so far. Argus ingests new FDA records daily.
What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3011286349.
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 Qualgen LLC

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 (2025). September 4, 2025 FDA Form 483 for Qualgen LLC — 5 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-qualgen-llc-2025-09-04-3011286349

MLA

"September 4, 2025 FDA Form 483 for Qualgen LLC — 5 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-qualgen-llc-2025-09-04-3011286349.

Chicago

Argus HQ Research. "September 4, 2025 FDA Form 483 for Qualgen LLC — 5 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-qualgen-llc-2025-09-04-3011286349.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_qualgen_llc_2025_09_04_3011286349_2025,
  title = {September 4, 2025 FDA Form 483 for Qualgen LLC — 5 Citations},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-qualgen-llc-2025-09-04-3011286349},
  note = {Accessed: July 15, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗