Warning letter
Aspire Pharmaceuticals, Inc.: warning letter of Nov 22, 2022
FDA warning letter 630328 · Division of Human and Animal Food Operations East II
Key facts
| Reference number | 630328 |
|---|---|
| Company | Aspire Pharmaceuticals, Inc. |
| Subject | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated |
| Issue date | Nov 22, 2022 |
| Posted date | Apr 4, 2023 |
| Issuing office | Division of Human and Animal Food Operations East II |
| Product type | Food/Cosmetics |
| CFR sections cited | 211.192, 111, 111.75(h)(1), 101.36(c), 111.75(d), 111.110(c), 211, 111.113(a)(1), 211.194(a), 211.160(b) |
| Inspection city | Somerset |
| Inspection ZIP | 08873-6800 |
| Inspection start date | Nov 29, 2021 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 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: