AllerQuest LLC
Form 483 issued May 3, 2021 · Plainville, Connecticut
- Inspection
- Apr 19 – May 3, 2021
- Observations
- 6
- Pages
- 6
- FEI number
- 3006900385
In short: On May 3, 2021, FDA issued a Form 483 with 6 observations to AllerQuest LLC in Plainville, Connecticut (FEI 3006900385) after an inspection that ran Apr 19 – May 3, 2021. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
5 of 6 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 04
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the…
This inspection in context
Questions about this 483
What did FDA find at AllerQuest LLC?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment 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.
When was AllerQuest LLC inspected by FDA?
The inspection ran Apr 19 – May 3, 2021, and the Form 483 is dated May 3, 2021.
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.