Nubratori, Inc.
Form 483 issued September 26, 2019 · Torrance, California
- Inspection
- Aug 26 – Sep 26, 2019
- Investigator
- Zachery L. Miller
- Observations
- 3
- Pages
- 3
- FEI number
- 3010166491
In short: On September 26, 2019, FDA issued a Form 483 with 3 observations to Nubratori, Inc. in Torrance, California (FEI 3010166491) after an inspection that ran Aug 26 – Sep 26, 2019. The investigator was Zachery L. Miller. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 2 of 3 observations.
Most cited: 21 CFR 211.113(b) (1×) · FDCA 501(a)(2)(A) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02FDCA 501(a)(2)(A)
Disinfectant contact time (also known as "dwell time") and coverage of the item being disinfected were…
- 03
Observation 3: scanned text, readable in the full document.
This inspection in context
Zachery L. Miller
17 documents · 2011–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Colorado.
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 3 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Nubratori, Inc.?
Zachery L. Miller is named on this Form 483, for the inspection of Aug 26 – Sep 26, 2019. Each investigator has a profile showing what they cite most.
When was Nubratori, Inc. inspected by FDA?
The inspection ran Aug 26 – Sep 26, 2019, and the Form 483 is dated September 26, 2019.
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.