Form 483 · FEI 3017580485
Form 483 issued July 12, 2023 · Amherst, Massachusetts
- Inspection
- Jul 11 – Jul 12, 2023
- Investigator
- Kwong P. Lee
- Observations
- 9
- Pages
- 6
- FEI number
- 3017580485
In short: On July 12, 2023, FDA issued a Form 483 with 9 observations to an FDA-inspected site in Amherst, Massachusetts (FEI 3017580485) after an inspection that ran Jul 11 – Jul 12, 2023. The investigator was Kwong P. Lee. Most observations concern design controls and cAPA; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
6 of 9 observations on this 483 concern design controls.
Most cited: 21 CFR 820.30(g) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Written MDR procedures have…
- 02
Procedures for corrective and preventive action…
- 03
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…
- 04
The design history file…
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 firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 9 observations on this Form 483, mostly about design controls and cAPA. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Kwong P. Lee is named on this Form 483, for the inspection of Jul 11 – Jul 12, 2023. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Jul 11 – Jul 12, 2023, and the Form 483 is dated July 12, 2023.
How do I get the full Form 483 for an FDA-inspected site?
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.