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 MedisourceRx had other FDA inspection citations?

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

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

FEI / inspection ID: 3013316698.

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.

MedisourceRx — FDA Form 483 Inspection, June 10, 2025 (1 Citations)

Key facts

Firm	MedisourceRx
FEI / inspection ID	3013316698
Inspection end date	June 10, 2025
Citation count	1

The short version: FDA inspected MedisourceRx in California and issued a Form 483 listing 1 inspectional observation following an inspection that concluded 2025-06-10. FDA records classify MedisourceRx 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 — DEPARTMENT OF H EALTH AND HUMAN SE RVI CES FOOD AND DRUG

DEPARTMENT OF H EALTH AND HUMAN SE RVI CES FOOD AND DRUG ADMINISTRATION

MedisourceRx’s FDA history

Argus HQ has recorded 1 total FDA action tied to MedisourceRx: 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 MedisourceRx had other FDA inspection citations?: This is the only FDA action Argus HQ has on file for MedisourceRx so far. Argus ingests new FDA records daily.
What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3013316698.
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 MedisourceRx

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). MedisourceRx — FDA Form 483 Inspection, June 10, 2025 (1 Citations). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-medisourcerx-2025-06-10-3013316698

MLA

"MedisourceRx — FDA Form 483 Inspection, June 10, 2025 (1 Citations)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-medisourcerx-2025-06-10-3013316698.

Chicago

Argus HQ Research. "MedisourceRx — FDA Form 483 Inspection, June 10, 2025 (1 Citations)." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-medisourcerx-2025-06-10-3013316698.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_medisourcerx_2025_06_10_3013316698_2025,
  title = {MedisourceRx — FDA Form 483 Inspection, June 10, 2025 (1 Citations)},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-medisourcerx-2025-06-10-3013316698},
  note = {Accessed: July 15, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗