Frostime Llc
Form 483 issued October 28, 2020 · New York, New York
- Inspection
- Oct 16 – Oct 28, 2020
- Investigator
- Kwong P. Lee
- Observations
- 1
- Pages
- 2
- FEI number
- 3016170334
In short: On October 28, 2020, FDA issued a Form 483 with 1 observation to Frostime Llc in New York, New York (FEI 3016170334) after an inspection that ran Oct 16 – Oct 28, 2020. The investigator was Kwong P. Lee. Most observations concern cAPA; the most-cited regulation is 21 CFR 803.17 (what are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 803.17 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written MDR procedures have…
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 firmFrostime Llc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.17
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Frostime Llc?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 803.17 (what are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?). The opening words of each observation are shown on this page.
Who inspected Frostime Llc?
Kwong P. Lee is named on this Form 483, for the inspection of Oct 16 – Oct 28, 2020. Each investigator has a profile showing what they cite most.
When was Frostime Llc inspected by FDA?
The inspection ran Oct 16 – Oct 28, 2020, and the Form 483 is dated October 28, 2020.
How do I get the full Form 483 for Frostime 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.