Warning letter
Samm Solutions, Inc., d.b.a. BTS Research: warning letter of Oct 20, 2023
FDA warning letter 663898 · Center for Drug Evaluation and Research | CDER
Key facts
| Reference number | 663898 |
|---|---|
| Company | Samm Solutions, Inc., d.b.a. BTS Research |
| Subject | Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies |
| Issue date | Oct 20, 2023 |
| Posted date | Oct 31, 2023 |
| Issuing office | Center for Drug Evaluation and Research | CDER |
| Product type | Drugs |
| CFR sections cited | 58, 58.35, 58.81, 58.185, 58.33(b), 58.33(f) |
| Inspection city | San Diego |
| Inspection ZIP | 92121-3932 |
| Inspection start date | Jun 27, 2022 |
| 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: