Warning letter
Respironics California Inc.: warning letter of Jan 27, 2004
FDA warning letter UCM146184 · Los Angeles District Office
Key facts
| Reference number | UCM146184 |
|---|---|
| Company | Respironics California Inc. |
| Subject | Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded |
| Issue date | Jan 27, 2004 |
| Posted date | Jan 27, 2004 |
| Issuing office | Los Angeles District Office |
| Product type | Devices |
| CFR sections cited | 803, 806, 806.10, 803.3(n), 803.3(r)(2), 803.50(a)(2), 806.2(j), 803.3(bb), 820, 803.18(d), 820.40, 806.10(a) and 1 more |
| Country | 3 |
| Inspection city | Carlsbad |
| Inspection ZIP | 92011-1517 |
| Inspection start date | May 29, 2003 |
| Letter on fda.gov | web.archive.org |
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: