Warning letter
Extended Care Air Therapy Systems, Inc.: warning letter of Aug 16, 2004
FDA warning letter UCM146551 · Cincinnati District Office
Key facts
| Reference number | UCM146551 |
|---|---|
| Company | Extended Care Air Therapy Systems, Inc. |
| Subject | Quality System Regulation/Adulterated |
| Issue date | Aug 16, 2004 |
| Posted date | Aug 16, 2004 |
| Issuing office | Cincinnati District Office |
| Product type | Devices |
| CFR sections cited | 803.17, 820 |
| Country | 3 |
| Inspection city | Roseville |
| Inspection ZIP | 43777-9706 |
| Inspection start date | Jun 28, 2004 |
| 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: