Warning letter
Michigan Instruments, Inc.: warning letter of Oct 1, 2001
FDA warning letter UCM178453 · Detroit District Office
Key facts
| Reference number | UCM178453 |
|---|---|
| Company | Michigan Instruments, Inc. |
| Subject | Medical Device Reporting Regulations/Lacks Premarket Notification/Adulterated/Misbranded |
| Issue date | Oct 1, 2001 |
| Posted date | Oct 1, 2001 |
| Issuing office | Detroit District Office |
| Product type | Devices |
| CFR sections cited | 11, 807.81(a)(3)(i), 806.2(i), 803.50(b)(2), 803 |
| Country | 3 |
| Inspection city | Grand Rapids |
| Inspection ZIP | 49512-5408 |
| Inspection start date | Jan 30, 2001 |
| Letter on fda.gov | web.archive.org |
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: