Warning letter
Monserrat Pharmaceuticals Inc: warning letter of Jan 20, 2004
FDA warning letter UCM146158 · San Juan District Office
Key facts
| Reference number | UCM146158 |
|---|---|
| Company | Monserrat Pharmaceuticals Inc |
| Subject | New Drug/Adulterated/Misbranded |
| Issue date | Jan 20, 2004 |
| Posted date | Jan 20, 2004 |
| Issuing office | San Juan District Office |
| Product type | Drugs |
| CFR sections cited | 211.188(a), 201.57(a), 211.137(a), 211.101(d), 211.188(b)(11), 200.51, 201.100, 211.25, 211.84, 211.166, 211.25(a), 211.67(b) and 3 more |
| Country | 3 |
| Inspection city | Aguas Buenas |
| Inspection ZIP | 00703-3208 |
| Inspection start date | Jul 10, 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: