AllerQuest LLC
Form 483 issued October 21, 2022 · Plainville, Connecticut
- Inspection
- Oct 4 – Oct 21, 2022
- Investigators
- Edmund F. Mrak· Lori M. Newman
- Observations
- 11
- Pages
- 10
- FEI number
- 3006900385
In short: On October 21, 2022, FDA issued a Form 483 with 11 observations to AllerQuest LLC in Plainville, Connecticut (FEI 3006900385) after an inspection that ran Oct 4 – Oct 21, 2022. The investigators were Edmund F. Mrak and Lori M. Newman. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and materials account for 7 of 11 observations.
What FDA observed
Preview: the opening words of each observation- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Procedures designed to prevent microbiological contamination of ding products purporting to be sterile are…
- 03
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Edmund F. Mrak
30 documents · 2010–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmAllerQuest LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AllerQuest LLC?
FDA listed 11 observations on this Form 483, mostly about facilities & equipment, materials and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected AllerQuest LLC?
Edmund F. Mrak and Lori M. Newman are named on this Form 483, for the inspection of Oct 4 – Oct 21, 2022. Each investigator has a profile showing what they cite most.
When was AllerQuest LLC inspected by FDA?
The inspection ran Oct 4 – Oct 21, 2022, and the Form 483 is dated October 21, 2022.
How do I get the full Form 483 for AllerQuest 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.