Nubratori, Inc.
Form 483 issued December 11, 2025 · To rrance, California
- Inspection
- Dec 1 – Dec 11, 2025
- Investigator
- Lucila B. Nwatu
- Observations
- 3
- Pages
- 5
- FEI number
- 3010166491
In short: On December 11, 2025, FDA issued a Form 483 with 3 observations to Nubratori, Inc. in To rrance, California (FEI 3010166491) after an inspection that ran Dec 1 – Dec 11, 2025. The investigator was Lucila B. Nwatu. Most observations concern production and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observation- 01
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 02
Your fom failed to establish adequate written procedures for production and process controls designed to assure…
- 03
Procedures designed to prevent microbiological contamination of diug products pmporting to be sterile are…
This inspection in context
Lucila B. Nwatu
18 documents · 2015–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmNubratori, Inc. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nubratori, Inc.?
FDA listed 3 observations on this Form 483, mostly about production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Nubratori, Inc.?
Lucila B. Nwatu is named on this Form 483, for the inspection of Dec 1 – Dec 11, 2025. Each investigator has a profile showing what they cite most.
When was Nubratori, Inc. inspected by FDA?
The inspection ran Dec 1 – Dec 11, 2025, and the Form 483 is dated December 11, 2025.
How do I get the full Form 483 for Nubratori, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.