Warning letter
Robbins Instruments, LLC: warning letter of Jan 21, 2025
FDA warning letter 687984 · "ORP: Office of Regulatory Programs, Office of Product Evaluation and Quality"
Key facts
| Reference number | 687984 |
|---|---|
| Company | Robbins Instruments, LLC |
| Subject | Medical Device/Misbranded/Unapproved Device/Quality System Regulation |
| Issue date | Jan 21, 2025 |
| Posted date | Feb 18, 2025 |
| Issuing office | "ORP: Office of Regulatory Programs, Office of Product Evaluation and Quality" |
| Product type | Devices |
| CFR sections cited | 803.50(a), 801, 803, 803.17, 830, 830.3, 803.10(c)(1), 803.17(a)(1), 803.17(a)(2), 803.17(a)(3), 803.17(b), 803.18(b)(1)(i) and 4 more |
| Inspection city | Houston |
| Inspection ZIP | 77007 |
| Inspection start date | Mar 27, 2024 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 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: