Has OSRX Inc had other FDA inspection citations?

Yes. Argus HQ has recorded 2 total FDA actions tied to OSRX Inc, including 2 Form 483 inspection citations.

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

FEI / inspection ID: 3014549846.

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 Form 483 — OSRX Inc (November 14, 2025)

Here's the summary: FDA inspected OSRX Inc in Montana and issued a Form 483 listing 3 inspectional observations following an inspection that concluded 2025-11-14. FDA records classify OSRX Inc 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.

Key facts

Firm	OSRX Inc
FEI / inspection ID	3014549846
Inspection end date	November 14, 2025
Citation count	3

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 — Written records of investigations into unexplained discrepancies do not always include the

Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up. Specifically, A. Your fum 's complaint system is not adequate. Complaints regarding quality do not always lead to an investigation, investigations or outcomes are not always documented and investigations are not always adequate. For example:

Observation 2 — The reproducibility of test methods have not been established

The reproducibility of test methods have not been established. Specifically, Your fnm uses 4 41 1 <bR >7 _a l bl< test method, for sterility testing release of finished diugs. However, there is no established procedure to identify or ganisms to the species in the event of a sterility failure.

Observation 3 — Appropriate controls are not exercised over computers or related systems to assure

Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. Specifically, Audit trail review of your instrnments HPLc ~m and HPLC"~l is not perfo1med for each analytical

OSRX Inc’s FDA history

Argus HQ has recorded 2 total FDA actions tied to OSRX Inc: 0 warning letters, 0 recalls, 0 approval records, and 2 Form 483 inspection citations.

Frequently asked questions

Has OSRX Inc had other FDA inspection citations?: Yes. Argus HQ has recorded 2 total FDA actions tied to OSRX Inc, including 2 Form 483 inspection citations.
What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3014549846.
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 OSRX Inc

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). FDA Form 483 — OSRX Inc (November 14, 2025) — 3 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-osrx-inc-2025-11-14-3014549846

MLA

"FDA Form 483 — OSRX Inc (November 14, 2025) — 3 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-osrx-inc-2025-11-14-3014549846.

Chicago

Argus HQ Research. "FDA Form 483 — OSRX Inc (November 14, 2025) — 3 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-osrx-inc-2025-11-14-3014549846.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_osrx_inc_2025_11_14_3014549846_2025,
  title = {FDA Form 483 — OSRX Inc (November 14, 2025) — 3 Citations},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-osrx-inc-2025-11-14-3014549846},
  note = {Accessed: July 15, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗