Warning letter
Altaire Pharmaceuticals, Inc.: warning letter of Mar 12, 2020
FDA warning letter 586153 · Division of Pharmaceutical Quality Operations I
Key facts
| Reference number | 586153 |
|---|---|
| Company | Altaire Pharmaceuticals, Inc. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Mar 12, 2020 |
| Posted date | May 26, 2020 |
| Issuing office | Division of Pharmaceutical Quality Operations I |
| Product type | Drugs |
| CFR sections cited | 211.160(b), 211.63, 211.28(a), 211.42(c)(10)(iv), 211.113(b) |
| Inspection city | Aquebogue |
| Inspection ZIP | 11931 |
| Inspection start date | Mar 25, 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: