Has Nubratori, Inc. had other FDA inspection citations?

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

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

FEI / inspection ID: 3010166491.

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 Nubratori, Inc.: Form 483 with 2 Citations (December 11, 2025)

Key facts

Firm	Nubratori, Inc.
FEI / inspection ID	3010166491
Inspection end date	December 11, 2025
Citation count	2

The short version: FDA inspected Nubratori, Inc. in California and issued a Form 483 listing 2 inspectional observations following an inspection that concluded 2025-12-11. FDA records classify Nubratori, 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.

Citations explained

Observation 1 — Written procedm es are n ot established fo r the cleaning and

Written procedm es are n ot established fo r the cleaning and maintenance of equipment, including utensils, us ed in the manufacture, process ing, packing or holding of a drng product. Specifically, a. Cleaning validation studies conduct ed in 2 01 7 relied on media fill activities as a smTogate rather than using residues from actual drng products. Sampling after a media fill does not represent worst-case cleaning conditions fo r therapeutic compounds and does not demonstrate the e ffectiveness of the cleaning process in removing active phaim aceutical ingredient (API) residues generated dming routine production. b. Cleaning validation studies conduct ed in 2 01 7 select ed [6 )(4) I non-sterile [6)(4) I as the worst-case product without ad equate scientific justification relative to all the sterile injectable drng products manufactm ed at the facility. Yow- fnm did n ot appropriately evaluate relevant worst-case factors such as therapeutic potency, solubility characteristics, toxicological prope1iies, and cleaning difficulty of shai·ed equipment,.

Observation 2 — Procedures designed to prevent microbiological contamination of diug products pmp orting to

Procedures designed to prevent microbiological contamination of diug products pmp orting to be sterile are not establish ed and written. Specifically: a. Your 2024 smoke studies do not include simulated set-up of environmental monitoring (EM) plates within the hood to demonstrate that EM preparation activities and plate placement do not compromise unidirectional airflow patterns or create turbulence that could introduce contamination to the critical zone. During my observation of the comp ounding of Lidocidex I (Dexamethasone Phosphate with Lidocaine HCl (3.33mg/6.67mg/ml), Lot C1 20325 01 , I obs erved personnel preparing EM samples inside the ISO 1:/ laminar airflow hood (LAFH) prior to compounding operations, including opening EM plate pa ckaging and labeling plates with non sterile markers. These activities introduced unnecessaiy pa1ticulate and microbial contamination risks and disrnpted unidirectional airflow essential for maintaining sterility. Your procedures fail to define appropriate locations fo r EM prepai·ation activities, resulting in uncontroll ed introduction of non-sterile items into the ISO □ environm.

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.

Nubratori, Inc.’s FDA history

Argus HQ has recorded 1 total FDA action tied to Nubratori, Inc.: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.

Frequently asked questions

Has Nubratori, Inc. had other FDA inspection citations?: This is the only FDA action Argus HQ has on file for Nubratori, Inc. so far. Argus ingests new FDA records daily.
What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3010166491.
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 Nubratori, 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 Inspects Nubratori, Inc.: Form 483 with 2 Citations (December 11, 2025). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-nubratori-inc-2025-12-11-3010166491

MLA

"FDA Inspects Nubratori, Inc.: Form 483 with 2 Citations (December 11, 2025)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-nubratori-inc-2025-12-11-3010166491.

Chicago

Argus HQ Research. "FDA Inspects Nubratori, Inc.: Form 483 with 2 Citations (December 11, 2025)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-nubratori-inc-2025-12-11-3010166491.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_nubratori_inc_2025_12_11_3010166491_2025,
  title = {FDA Inspects Nubratori, Inc.: Form 483 with 2 Citations (December 11, 2025)},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-nubratori-inc-2025-12-11-3010166491},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗