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

FEI / inspection ID: 3014483112.

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.

FDA Inspects IntegraDose Compounding Services LLC: Form 483 with 2 Citations (August 12, 2026)

Q: Has IntegraDose Compounding Services LLC had other FDA inspection citations?

Yes. Argus HQ has recorded 4 total FDA actions tied to IntegraDose Compounding Services LLC, including 2 Form 483 inspection citations.

Key facts

Firm	IntegraDose Compounding Services LLC
FEI / inspection ID	3014483112
Inspection end date	August 12, 2026
Citation count	2

The short version: FDA inspected IntegraDose Compounding Services LLC in Minnesota and issued a Form 483 listing 2 inspectional observations following an inspection that concluded 2026-08-12. FDA records classify IntegraDose Compounding Services 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. 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.

Citations explained

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

The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. Specifically, A. Your firm qualifies visual inspectors and AQL inspectors on [(1:5) (4) I basis. The following deficiencies in inspector qualification were identified during the inspection: 1. Following the start of operations at your new facility on February 2, 2026, your firm did not perform requalification of visual inspectors or AQL inspectors for the new facility. Instead, your firm continued to use qualifications performed at your previous facility. No assessment or justification for carrying over previous facility qualifications to the new facility was identified during the inspection. Visual inspection qualification is specific to the environment and equipment under which it is performed and qualifications conducted at a previous facility cannot be assumed to remain valid under the different conditions of a new facility. EM PLOYEE(S) SlGNATURE D ATE I SSUED SEE REV ERS E S ara h M Ga u na , FDA Ce nt er Emplo ye e 8/ 1 2/2026 OF THIS PAG E Mary-Jea n et Mcg a rry , FDA Cen t er Emp l o y ee S. w~-;;;r~m, r~h MG;iun. X ~~nod: Oe.t 2-2026 PAGE 3 of8 PAGES FORM FDA

Observation 3 — Procedures design ed to prevent microbiological contamination of drug products purporting

Procedures design ed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process. Specifically, Smoke studies conducted on December 31, 2025, did not adequately reflect observed production operations. On August 5, 2026, video recordings of the production of Hydromorphone HCL 20mg/l0OmL CADDS lot #20260720HYD-1 , EXP November 17, 2026, completed on n 6)~(21- n , were reviewed. The following discrepancies were observed in the smoke study videos: 1.The batch video, during production, showed(b)<4l operators performing individual tasks in each TSO 5 Laminar Airflow Hood (LAFH). The smoke studies only demonstrated one operator individually performing one task in each video. 2. The smoke study for the CADDs products shows the CADDs lined up with about 2 - 3 inches of space between the CADD and the back wall ofthe n:Df(4J7 airflow LAFH. During the batch video the CADDs were observed to be placed directly in front of the back wall with no gap. The smoke study did not evaluate t hi s product placement configuration and therefore does not demonstrate that unidirectional airflow adequately protects the critical c

IntegraDose Compounding Services LLC’s FDA history

Argus HQ has recorded 4 total FDA actions tied to IntegraDose Compounding Services LLC: 0 warning letters, 2 recalls, 0 approval records, and 2 Form 483 inspection citations.

Frequently asked questions

Has IntegraDose Compounding Services LLC had other FDA inspection citations?: Yes. Argus HQ has recorded 4 total FDA actions tied to IntegraDose Compounding Services LLC, including 2 Form 483 inspection citations.
What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3014483112.
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.

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Full FDA history for IntegraDose Compounding Services 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 (2026). FDA Inspects IntegraDose Compounding Services LLC: Form 483 with 2 Citations (August 12, 2026). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/483/integradose-compounding-services-3014483112-2026-08-12

MLA

"FDA Inspects IntegraDose Compounding Services LLC: Form 483 with 2 Citations (August 12, 2026)." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/483/integradose-compounding-services-3014483112-2026-08-12.

Chicago

Argus HQ Research. "FDA Inspects IntegraDose Compounding Services LLC: Form 483 with 2 Citations (August 12, 2026)." Digital Empire Holdings LLC. Accessed September 23, 2026. https://argushq.ai/483/integradose-compounding-services-3014483112-2026-08-12.

BibTeX

@misc{argushq_argushq_ai_483_integradose_compounding_services_3014483112_2026_08_12_2026,
  title = {FDA Inspects IntegraDose Compounding Services LLC: Form 483 with 2 Citations (August 12, 2026)},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/483/integradose-compounding-services-3014483112-2026-08-12},
  note = {Accessed: September 23, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗