Warning letter
Respi Care Group of Puerto Rico: warning letter of Dec 20, 2004
FDA warning letter UCM146721 · San Juan District Office
Key facts
| Reference number | UCM146721 |
|---|---|
| Company | Respi Care Group of Puerto Rico |
| Subject | Unapproved New Drug/Adulterated/Misbranded |
| Issue date | Dec 20, 2004 |
| Posted date | Dec 20, 2004 |
| Issuing office | San Juan District Office |
| Product type | Drugs |
| CFR sections cited | 200.51, 210, 211.22, 211.165, 211.166, 211.42(c)(10), 211.67(a), 211.67(b), 211.84(d)(2), 211.100(a), 211.113(b), 211.160(b) and 2 more |
| Country | 3 |
| Inspection city | Caguas |
| Inspection ZIP | 00725 |
| Inspection start date | Jun 9, 2004 |
| 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: