Nubratori, Inc.
Form 483 issued July 26, 2024 · Torrance, California
- Inspection
- Jul 16 – Jul 26, 2024
- Investigator
- Lucila B. Nwatu
- Observations
- 7
- Pages
- 7
- FEI number
- 3010166491
In short: On July 26, 2024, FDA issued a Form 483 with 7 observations to Nubratori, Inc. in Torrance, California (FEI 3010166491) after an inspection that ran Jul 16 – Jul 26, 2024. The investigator was Lucila B. Nwatu. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate…
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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nubratori, Inc.?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, materials and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). 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 Jul 16 – Jul 26, 2024. Each investigator has a profile showing what they cite most.
When was Nubratori, Inc. inspected by FDA?
The inspection ran Jul 16 – Jul 26, 2024, and the Form 483 is dated July 26, 2024.
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.