Warning letter
Rechon Life Science AB: warning letter of Apr 30, 2025
FDA warning letter 701040 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 701040 |
|---|---|
| Company | Rechon Life Science AB |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Apr 30, 2025 |
| Posted date | Jun 3, 2025 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| CFR sections cited | 211.42(c)(10)(v), 211.58, 211.113(b), 211.192 |
| Inspection city | Limhamn |
| Inspection start date | Aug 26, 2024 |
| 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: