Acorn NMR Inc
Form 483 issued December 11, 2015 · Livermore, California
- Inspection
- Dec 8 – Dec 11, 2015
- Investigators
- David Eng· Lucila B. Nwatu
- Observations
- 3
- Pages
- 3
- FEI number
- 3004901666
In short: On December 11, 2015, FDA issued a Form 483 with 3 observations to Acorn NMR Inc in Livermore, California (FEI 3004901666) after an inspection that ran Dec 8 – Dec 11, 2015. The investigators were David Eng and Lucila B. Nwatu. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
3 of 3 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, and test…
- 02
Written specifications for laboratory controls do not include a description of…
- 03
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are…
This inspection in context
David Eng
5 documents · 2015–2016
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmAcorn NMR Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Acorn NMR Inc?
FDA listed 3 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Acorn NMR Inc?
David Eng and Lucila B. Nwatu are named on this Form 483, for the inspection of Dec 8 – Dec 11, 2015. Each investigator has a profile showing what they cite most.
When was Acorn NMR Inc inspected by FDA?
The inspection ran Dec 8 – Dec 11, 2015, and the Form 483 is dated December 11, 2015.
How do I get the full Form 483 for Acorn NMR 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.