AllerQuest LLC
FDA inspection history in Plainville, Connecticut, 2019 to 2022
- 3
- Form 483s
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
2019: one close-out letter and one Form 483; 2021: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–22Three Form 483s and one close-out letter, at Plainville, Connecticut.
- 2019The longest 483 on file: 15 observations over 23 pages at Plainville, Connecticut.
Cited most
Across all AllerQuest observations on file
- 21 CFR 211.42Design and construction features7
- 21 CFR 211.192Production record review3
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.113Control of microbiological contamination2
The complete AllerQuest file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Plainville, Connecticut
Three Form 483s and one close-out letter · 2019 to 2022 · 32 observations
Latest: Form 483, Oct 21, 2022 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-10-21 | 483 Form 483 | Plainville, Connecticut | 11 | $99 |
| 2021-05-03 | 483 Form 483 | Plainville, Connecticut | 6 | $99 |
| 2019-06-24 | Close-out Close-out letter | Plainville, Connecticut | — | $99 |
| 2019-03-01 | 483 Form 483 | Plainville, Connecticut | 15 | $99 |
Investigators on these documents
FEI number 3006900385 · most recent document Oct 21, 2022
About AllerQuest LLC
How many FDA Form 483s has AllerQuest LLC received?
FDA Intel has 3 Form 483s on file for AllerQuest LLC; the most recent is dated Oct 21, 2022.
When was AllerQuest LLC last inspected by FDA?
The most recent FDA inspection document on file for AllerQuest LLC is a Form 483 dated Oct 21, 2022, for the site in Plainville, Connecticut.
What did FDA cite at AllerQuest LLC?
The regulations cited most in the observations on file for AllerQuest LLC are 21 CFR 211.42 (Design and construction features), 7 times; 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 3 times.