Warning letter
RIJ Pharmaceutical LLC: warning letter of Mar 28, 2019
FDA warning letter 558815 · Division of Pharmaceutical Quality Operations I
Key facts
| Reference number | 558815 |
|---|---|
| Company | RIJ Pharmaceutical LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Mar 28, 2019 |
| Posted date | Apr 16, 2019 |
| Issuing office | Division of Pharmaceutical Quality Operations I |
| Product type | Drugs |
| CFR sections cited | 211.34, 211.192, 211.22(d), 211.100(a), 211.160(b), 211.194(a) |
| Inspection city | Middletown |
| Inspection ZIP | 10941 |
| Inspection start date | Apr 3, 2018 |
| 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: