Warning letter
Novel Laboratories, Inc. d.b.a LUPIN: warning letter of Jun 11, 2021
FDA warning letter 613385 · Office of Pharmaceutical Quality Operations Division I
Key facts
| Reference number | 613385 |
|---|---|
| Company | Novel Laboratories, Inc. d.b.a LUPIN |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Jun 11, 2021 |
| Posted date | Jun 29, 2021 |
| Issuing office | Office of Pharmaceutical Quality Operations Division I |
| Product type | Drugs |
| CFR sections cited | 211.22(d), 211.67(a), 211.67(b), 211.100(a) |
| Inspection city | Somerset |
| Inspection ZIP | 08873 |
| Inspection start date | Sep 10, 2020 |
| 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: