Warning letter
Imprimis NJOF, LLC: warning letter of Jun 7, 2019
FDA warning letter 553322 · Division of Pharmaceutical Quality Operations I
Key facts
| Reference number | 553322 |
|---|---|
| Company | Imprimis NJOF, LLC |
| Subject | Drug Product/Adulterated |
| Issue date | Jun 7, 2019 |
| Posted date | Jul 9, 2019 |
| Issuing office | Division of Pharmaceutical Quality Operations I |
| Product type | Drugs |
| CFR sections cited | 210.1(b), 211.84(d)(3), 201.115, 211.192, 310.305, 200.10(b), 211.22(a), 211.42(c)(10)(iv) |
| Inspection city | Ledgewood |
| Inspection ZIP | 07852 |
| Inspection start date | Apr 24, 2017 |
| 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: