Warning letter
Acino Products, LLC: warning letter of Feb 10, 2020
FDA warning letter 589471 · Division of Pharmaceutical Quality Operations I
Key facts
| Reference number | 589471 |
|---|---|
| Company | Acino Products, LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Feb 10, 2020 |
| Posted date | Mar 3, 2020 |
| Issuing office | Division of Pharmaceutical Quality Operations I |
| Product type | Drugs |
| CFR sections cited | 211.194(a), 211.58, 211.67(a), 211.34 |
| Inspection city | Hamilton |
| Inspection ZIP | 08691-1642 |
| Inspection start date | May 28, 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: