J & J Instruments, LLC
Form 483 issued September 16, 2020 · Stratford, Connecticut
- Inspection
- Sep 15 – Sep 16, 2020
- Investigator
- Kwong P. Lee
- Observations
- 1
- Pages
- 3
- FEI number
- 2246990
In short: On September 16, 2020, FDA issued a Form 483 with 1 observation to J & J Instruments, LLC in Stratford, Connecticut (FEI 2246990) after an inspection that ran Sep 15 – Sep 16, 2020. The investigator was Kwong P. Lee. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.198(e) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Records of complaint investigations do…
This inspection in context
Kwong P. Lee
12 documents · 2015–2026
Cites 820.30(c) (design controls) more than any other section. Most of their documents are for sites in New York.
The firmJ & J Instruments, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at J & J Instruments, LLC?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected J & J Instruments, LLC?
Kwong P. Lee is named on this Form 483, for the inspection of Sep 15 – Sep 16, 2020. Each investigator has a profile showing what they cite most.
When was J & J Instruments, LLC inspected by FDA?
The inspection ran Sep 15 – Sep 16, 2020, and the Form 483 is dated September 16, 2020.
How do I get the full Form 483 for J & J Instruments, LLC?
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.