James Alexander Corporation
Form 483 issued February 27, 2019 · Blairstown, New Jersey
- Inspection
- Feb 15 – Feb 27, 2019
- Investigator
- Gurnard Toi
- Observations
- 1
- Pages
- 1
- FEI number
- 2242239
In short: On February 27, 2019, FDA issued a Form 483 with 1 observation to James Alexander Corporation in Blairstown, New Jersey (FEI 2242239) after an inspection that ran Feb 15 – Feb 27, 2019. The investigator was Gurnard Toi. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures applicable to the quality control unit are not deficiently written and…
This inspection in context
Gurnard Toi
1 document · 2019
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New Jersey.
The firmJames Alexander Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at James Alexander Corporation?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected James Alexander Corporation?
Gurnard Toi is named on this Form 483, for the inspection of Feb 15 – Feb 27, 2019. Each investigator has a profile showing what they cite most.
When was James Alexander Corporation inspected by FDA?
The inspection ran Feb 15 – Feb 27, 2019, and the Form 483 is dated February 27, 2019.
How do I get the full Form 483 for James Alexander Corporation?
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.