Warning letter
Analytical Control Systems, Inc: warning letter of May 8, 2014
FDA warning letter 417234 · Detroit District Office
Key facts
| Reference number | 417234 |
|---|---|
| Company | Analytical Control Systems, Inc |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | May 8, 2014 |
| Posted date | May 8, 2014 |
| Issuing office | Detroit District Office |
| Product type | Devices |
| CFR sections cited | 803.17, 807.81(b), 806.20, 806, 806.10(a)(2), 820.40, 820, 803 |
| Inspection city | Fishers |
| Inspection ZIP | 46038 |
| Inspection start date | Oct 29, 2013 |
| 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: