Warning letter
Aire-Master of America, Inc.: warning letter of May 23, 2022
FDA warning letter 622546 · Division of Pharmaceutical Quality Operations III
Key facts
| Reference number | 622546 |
|---|---|
| Company | Aire-Master of America, Inc. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | May 23, 2022 |
| Posted date | Jun 7, 2022 |
| Issuing office | Division of Pharmaceutical Quality Operations III |
| Product type | Drugs |
| CFR sections cited | 330, 201.128, 211.192, 211.198, 201.61(a), 211.67(a), 211.84(d)(1), 211.160(b), 211.165(b) |
| Inspection city | Nixa |
| Inspection ZIP | 65714 |
| Inspection start date | Oct 5, 2021 |
| 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: