AllerQuest LLC
Form 483 issued March 1, 2019 · Plainville, Connecticut
- Inspection
- Jan 31 – Mar 1, 2019
- Investigator
- Jonah S. Ufferfilge
- Observations
- 15
- Pages
- 23
- FEI number
- 3006900385
In short: On March 1, 2019, FDA issued a Form 483 with 15 observations to AllerQuest LLC in Plainville, Connecticut (FEI 3006900385) after an inspection that ran Jan 31 – Mar 1, 2019. The investigator was Jonah S. Ufferfilge. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 9 of 15 observations.
Most cited: 21 CFR 211.42 (2×) · 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Jonah S. Ufferfilge
17 documents · 2019–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Connecticut.
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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AllerQuest LLC?
FDA listed 15 observations on this Form 483, mostly about facilities & equipment, production and quality system. 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?
Jonah S. Ufferfilge is named on this Form 483, for the inspection of Jan 31 – Mar 1, 2019. Each investigator has a profile showing what they cite most.
When was AllerQuest LLC inspected by FDA?
The inspection ran Jan 31 – Mar 1, 2019, and the Form 483 is dated March 1, 2019.
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.