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 OSRX Inc. 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.

FDA Inspects OSRX Inc.: Form 483 with 3 Citations (October 25, 2024)

At a glance: FDA inspected OSRX Inc. in Montana, United States and issued a Form 483 listing 3 inspectional observations following an inspection that concluded 2024-10-25. 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	October 25, 2024
Citation count	3

Citations explained

Observation 1 — Procedures designed to prevent microbiological contamination of diug products pmp o1ting to

Procedures designed to prevent microbiological contamination of diug products pmp o1ting to be sterile are not establish ed and followed. Specifically, A. Your fnm ' s personal m edia fill is deficient in that aseptic operators only aseptically fill n• containers units, [(6) (4) I, to fully quali fy their sterile operators, under procedure, SOP- CC-0003, Personnel Media Fill Qualification. For example, to successfully qualify operator, tort6J;t•r(7) to produce sterile di11g product in your cleam oom only P>T(4 ) units were filled aseptically, taking a total of[(o) ·c4) Ito manufacture. This is not an a de quate assessment of an operators aseptic technique when manufacturing a maximum batch size of tbf{4J units that take~(l:5) (4) to complete. B. Your fnm fa il ed to incubate all integral units of the m edia fill per fo1med under protocol VALRPT-001 . In Cle amoom Suite 100, the fo llowing units were fill ed in ISO 5 BSC and then removed for ~6J.

Observation 2 — There is a failure to thoroughly review any unexplained discrepancy and the

There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of i ts componen ts to meet any of its specifications whether or not the batch has been ah-eady distribute d. Specifically, A) Your fnm failed to thoroughly investigation quality even ts that had enviro nmenta l monitoring recoveries that exceeded specification limi ts without adequate corrective actions, scientific justification, and impact assessment documented. For example, i. QA-2024-0048 was initiated due to 1 c fu recove1y of Stap hylococcus epidermidis on an ISO 5 active vi ab le air sample plate that was per fo1med during the production of Brimonidine tartrate/ dorzolainide 1%2%, Lo t{{6)1~ , BUD: 23July2024. The batch was released without the proper batch impact assessmen t, con ective actions, and scientific rationale applied to the event prior to releasing and distributing the diug product to market. ii. QA-2024-0071 was initiated due several enviro nmental recoveries in Cleanroom Sui te.

Observation 3 — Aseptic processing areas are de fi cient regarding the system fo r

Aseptic processing areas are de fi cient regarding the system fo r monitoring environmental conditions. Specifically, A) There are no ISO 5 viable surface samples taken during the earlier lots being manufactur ed in clean room# , (ISO7) and clean room#D (IS0 7) on each day of aseptic productio n. For exampl e, Atropine 0.01 %, Sulfate Monohydi·ate, Lot (6) (~ , , B~ t 4Apr25, and Prednisolone Phosphate 1% / Moxifloxacin 0.5% / Bromfenac 0.075%, L ot( D) (~) , BUD: 15Apr25, both were manufactured on[{6) {21-) Iand did not have an associated surface sample of the ISO 5 Biosafety Cabinet perfo 1med at the end of each batch operation. B) Your fnm 's procedure, SOP-CC-0026, Routine Environmental Mo nitoring Cleanroom JOO , lists the action level for viable surface sample at fl4 colonies per fo1ming units per sampling device, which is not appropriate fo r an ISO 5 environmen t. C) On 10/17/2024, I observed a fingertip sample.

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.

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

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 OSRX Inc. 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.

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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 (2024). FDA Inspects OSRX Inc.: Form 483 with 3 Citations (October 25, 2024). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-osrx-inc-2024-10-25-3014549846

MLA

"FDA Inspects OSRX Inc.: Form 483 with 3 Citations (October 25, 2024)." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/483/fda-483-osrx-inc-2024-10-25-3014549846.

Chicago

Argus HQ Research. "FDA Inspects OSRX Inc.: Form 483 with 3 Citations (October 25, 2024)." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-osrx-inc-2024-10-25-3014549846.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_osrx_inc_2024_10_25_3014549846_2024,
  title = {FDA Inspects OSRX Inc.: Form 483 with 3 Citations (October 25, 2024)},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-osrx-inc-2024-10-25-3014549846},
  note = {Accessed: July 15, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗