Warning letter
Automated Ophthalmics, Inc.: warning letter of Jun 5, 2013
FDA warning letter 395044 · Baltimore District Office
Key facts
| Reference number | 395044 |
|---|---|
| Company | Automated Ophthalmics, Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Jun 5, 2013 |
| Posted date | Jun 5, 2013 |
| Issuing office | Baltimore District Office |
| Product type | Devices |
| CFR sections cited | 803.17, 803, 820 |
| Inspection city | Elkridge |
| Inspection ZIP | 21075 |
| Inspection start date | Feb 28, 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: