Warning letter
N-Molecular Inc. d.b.a. SOFIE: warning letter of Sep 24, 2018
FDA warning letter 553833 · Center for Drug Evaluation and Research
Key facts
| Reference number | 553833 |
|---|---|
| Company | N-Molecular Inc. d.b.a. SOFIE |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded |
| Issue date | Sep 24, 2018 |
| Posted date | Oct 2, 2018 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 212, 212.20(c), 212.20(d), 212.30(a) |
| Inspection city | Haverhill |
| Inspection ZIP | 01835 |
| Inspection start date | Feb 12, 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: