Warning letter
AllerQuest LLC: warning letter of Jun 24, 2019
FDA warning letter 578557 · Center for Drug Evaluation and Research
Key facts
| Reference number | 578557 |
|---|---|
| Company | AllerQuest LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Jun 24, 2019 |
| Posted date | Jul 9, 2019 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 211.42(c)(10), 211.34, 211.192, 211.42(c) |
| Inspection city | Plainville |
| Inspection ZIP | 06062 |
| Inspection start date | Jan 31, 2019 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: